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Smiths Medical No Longer Selling Cozmo Insulin Pumps
March 27th, 2009 | 
Author: March 25, 2009
SMITHS MEDICAL ANNOUNCES INTENT TO STOP SELLING DELTEC COZMO® INSULIN PUMPS
Decision Represents First Step in Orderly Exit from the Diabetes Business Over Time
ST. PAUL, Minn. – 25 March 2009 – Smiths Medical announced today its intent to stop selling the Deltec Cozmo® insulin pump, and manage an orderly, carefully controlled exit from the diabetes business over time.
“The continued health of the thousands of people who use the Deltec Cozmo® insulin pump is our primary concern, and they should be reassured that their pump remains an excellent choice to help them manage their diabetes,” said Srini Seshadri, president of Smiths Medical. “Our customers also should also be reassured that Smiths Medical will meet all of its warranty obligations; provide customer and clinical support for the lifetime of the warranty of all pumps; ensure that Deltec Cozmo® insulin pump cartridges and Cleo® and Comfort® infusion sets are available; and make any necessary transitions as simple as possible.”
For people with a Deltec Cozmo® insulin pump, today’s announcement means two important things:
* When the pump approaches the end of its warranty period, customers should consult with their healthcare provider to choose a pump from another manufacturer.
* Smiths Medical will work with pump users to transfer purchases of cartridges and infusion sets to one of the many national and/or regional distributors that stock these items. (Anyone who already is familiar with a distributor should feel free to contact that company immediately and start ordering supplies directly.)
* NOTE: Pump users outside of the United States may continue to purchase disposable cartridges and infusion sets from their local Smiths Medical distributor, a list of which can be found at www.DeltecCozmoUpdate.com.
For more information, including distributor contact details, U.S. and International pump users and healthcare professionals should visit www.DeltecCozmoUpdate.com. In the United States, people may also contact the Smiths Medical customer support team at 1-800-826-9703.
Why Smiths Medical Made This Decision
Smiths Medical considered many possible options to create a long-term, sustainable diabetes business. However, after reviewing these options, it was decided that the best course of action is to exit the diabetes market.
In addition, as its only direct-to-consumer enterprise, the Diabetes business has little synergy with the rest of Smiths Medical’s businesses. For this reason, Diabetes requires its own extensive sales, marketing, reimbursement, insurance and clinical support infrastructure in the United States, which has resulted in it becoming uneconomical as sales and profits for the business have decreased. Without a strong, profitable Diabetes business in the United States, the world’s largest medical market, it would also be impossible to sustain the business internationally.
Finally, dramatic changes have taken place in the diabetes market during the past three years, including:
* The market has evolved from a familiar hardware-plus-disposables model to an integrated diabetes management model that would require significant ongoing investments in continuous glucose monitoring.
* Smiths Medical’s shrinking market share has been exacerbated by the aggressive pursuit of market share growth by two large and well-resourced players – Medtronic, which has the largest share of the U.S. insulin-pump therapy market, and J&J.
* A considerable amount of intellectual property has been established in the diabetes segment, which makes the development of next-generation products very costly, and risky in terms of the potential for future patent disputes.
“Throughout our involvement in the diabetes market, we have chosen always to put care for our customer first, providing excellent clinical support, maintaining the integrity of our warranty and being proactive about fixing issues as they arose,” said Seshadri. “For our efforts, we have been rewarded with a core group of very loyal customers. We thank them and reiterate our commitment to making this transition as easy as possible.”
What This Decision Means for Diabetes Employees
The decision to stop selling pumps means that 51 people working in the Diabetes business will be affected immediately, primarily in field sales, marketing and, to a lesser extent, clinical services, customer support and manufacturing. Smiths Medical will retain enough dedicated staff to ensure that it meets its obligations for the remaining warranty period on pumps already sold. The company will continue to offer a pump recertification service for existing pumps that may need to be replaced during their warranty period.
About Smiths Medical
Smiths Medical is a leading supplier of high-quality medical devices and products for global markets. It designs and manufactures specialist medical devices in three key areas: Safety Devices, Vital Care and Medication Delivery.
Smiths Medical’s customers include hospitals, alternate care such as home care, and other healthcare providers worldwide. Smiths Medical is part of the global technology business Smiths Group, a world leader in the practical application of advanced technologies. Smiths is a global technology company listed on the London Stock Exchange. For further information, visit www.smiths-medical.com.
CONTACT: Bob Hanvik, Tel: +1.651.628.7613, Mobile: +1.612.812.2433
Posted in Diabetes In the News, FDA Alerts, Recalls, Product Safety | Tags: cozmo insulin pumps, smiths medical | 
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FDA Recall – ReliOn Insulin Syringes 1cc 31g
Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge
Class 1 Recall
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Date Recall
Initiated: |
October 9, 2008 |
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Product:
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ReliOn Insulin Syringes, 1cc, 31-gauge, 100 units for use with U-100 insulin, Lot Number 813900, Product Code 38396-0403-02
Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are subject to this recall. T his product was manufactured in June 2008 and distributed from July through October 8, 2008. |
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Use:
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An insulin injection is used to control blood sugar in people who have type 1 or type 2 diabetes and who cannot control their diabetes with oral medicines. |
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Recalling Firm:
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Covidien LP 15 Hampshire St Mansfield, Massachusetts 02048-1113 |
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Reason for Recall:
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Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia (abnormally low level of blood sugar), serious health consequences, and even death. |
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Public Contact:
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Customers may return the recalled product to their local Wal-Mart store or Sam’s Club pharmacy for replacement product. Consumers and healthcare professionals who suspect they have the recalled product may also contact Covidien at 1-866-780-5436 or Relion for more information. |
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FDA District:
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New England |
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FDA Comment:
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Tyco Healthcare Group, LP (Covidien) notified Can-Am Care, Corporation (the distributor of these syringes) by letter sent by e-mail and by Federal Express on October 9, 2008. The letter requests that they immediately:
Can-Am Care, whose name appears on the product label, has also posted a notice on their website. Wal-Mart and Sam’s Clubs conducted consumer mailings on Oct. 14, 2008, posted the recall announcement in their stores, and on Wal-Mart’s website, and are posting placards (posters) in their stores. Wal-Mart and Sam’s Club are asking their customers to return ReliOn 1cc, 31-gauge syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam’s Club pharmacy for a replacement product. For additional information, see the FDA Press Release. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program. See the nearby link to MedWatch. Source: FDA Alerts |
FDA Recall – Animas Pump Battery Caps
Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Class 1 Recall
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Date Recall
Initiated: |
August 4, 2008 |
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Product:
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Battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008. |
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Use:
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An insulin pump helps administer insulin to maintain proper levels of blood glucose. |
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Recalling Firm:
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Animas Corporation 200 Lawrence Dr West Chester, Pennsylvania 19380 |
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Reason for Recall:
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There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). |
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Public Contact:
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The company may be contacted Monday through Friday at 1-866-423-4087 from 8:00 a.m. until 7:00 pm Eastern Standard Time. |
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FDA District:
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Philadelphia |
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FDA Comment:
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Between August 18, 2008 and September 1, 2008, the company sent letters to the patients by certified mail to inform them that the defective battery cap may not maintain contact with the pump’s battery compartment. As a result, the affected pump may inadvertently shut down. The company included replacement battery caps with the letter.
The company advised their patients to immediately replace the battery cap on their insulin pump with a battery cap enclosed with the letter. Patients were directed to follow the instructions in the User Guide for changing the battery cap. Patients were also instructed to discard the defective battery caps and discontinue any further use of them. The company also sent letters to their distributors alerting them to the battery cap failure on the insulin pumps and provided instructions for retrieval, replacement, and disposal of the defective battery caps. The company is continuing their efforts to contact all patients who have not acknowledged receipt of the letter. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program. See the nearby link to MedWatch. Source: FDA Alerts |
BYETTA May Be Causing Pancreatitis and Death
October 16, 2007
For those who may be using BYETTA (which may be prescribed for PCOS, pre-diabetes, type 2, or LADA) the FDA has issued warnings about patients using BYETTA developing pancreatitis.
Exenatide (marketed as Byetta)
FDA ALERT [10/2007]: FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases.
Healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.
The Byetta full prescribing information will include new information in the PRECAUTIONS section about the potential for acute pancreatitis in patients taking Byetta.
Recommendations and Considerations
- Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.
- Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.
Information for the patient: Physicians who prescribe Byetta should discuss with their patients:
Byetta is a medicine given by injection to help treat adults with type 2 diabetes. Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort. However, the presence of unexplained, severe abdominal pain, with or without nausea and vomiting, raises the suspicion of acute pancreatitis, a potentially serious condition that requires prompt medical attention. Therefore, patients taking Byetta should promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.
Background Information and Data
FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients treated with Byetta. Twenty-seven of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use. In six patients the symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily. Twenty-one patients were hospitalized. There were no reports of hemorrhagic or necrotizing pancreatitis. However, five patients developed serious complications including dehydration and renal failure; suspected ileus; phlegmon; and ascites. Twenty-two of the 30 reports indicated that the patients improved after discontinuing Byetta.
Details in three reports indicated that the symptoms of acute pancreatitis returned when Byetta was restarted. Nausea and vomiting returned in two patients when Byetta was restarted. In a third patient, abdominal pain returned when Byetta was restarted and abated after Byetta was permanently discontinued.
FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the Precautions section of the product label.
Source: FDA Alerts
A1cNow Not Accurate for Children with Type 1 Diabetes
Tuesday, January 16, 2007 – NEW YORK (Reuters Health) – A portable device called A1cNow, which is designed to provide a long-term picture of blood sugar control, does not provide accurate or consistent results in children with type 1 diabetes, researchers report in the journal Diabetes Care.
Read the article
