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FDA Says Medtronic Took 2 Years to Recall Defective Pumps
July 10th, 2009 | 
Author: July 11, 2009
The Wall Street Journal
by Jon Kamp
Medtronic Recalls Insulin Devices
The following is an excerpt from one of many articles relating to the recent Medtronic infusion set recall of approximately 3 million sets.
Late last month, the medical-device maker came under fire from the U.S. Food and Drug Administration, which warned Medtronic about what the agency called a failure to properly report and remedy flaws in the Synchromed drug pump and the MiniMed insulin pump.
In a letter, the FDA said it took Medtronic almost two years to recall Synchromed II pumps after discovering a missing propellant in some versions. The agency also said the company didn’t follow proper reporting procedures involving complaints about the insulin pump.
Posted in FDA Alerts, Recalls, Product Safety | Tags: insulin pumps, medtronic, recalls | 
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FDA Early Communication About the Safety of Lantus (Insulin Glargine)
07/01/2009
Lantus Has Been Linked to Increased Risk of Cancer
FDA is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.
Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. Patients should also contact their healthcare professional if they have concerns about the medicines they are taking.
Source: FDA Advisory
Posted in FDA Alerts, Recalls, Product Safety | Tags: cancer, fad advisory, fda alerts, insulin glargine, lantus |
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Medtronic MiniMed Paradigm Quick-Set Infusion Set Recalls
Medtronic MiniMed Paradigm Quick-Set Infusion Sets
| Recall Class: | Class I |
| Date Recall Initiated: |
June 29, 2009 |
| Product: | Paradigm Quick-Set Infusion Sets, Models MMT-396, MMT-397, MMT-398, and MMT-399 (with lot numbers beginning with “8,” for example 8XXXXXX)The lot number is clearly marked on both the product label, and on each individual infusion set package.
Only “Lot 8” Paradigm Quick-set infusion sets are affected by this recall. These devices were manufactured and distributed from December 1, 2007 through June 18, 2009. |
| Use: | An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient. |
| Recalling Firm: | Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325 |
| Reason for Recall: | These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death. |
| Public Contact: | The company may be contacted anytime, 24 hours a day, seven days a week.Physicians:
Patients/Customers:
See additional information under Useful Links below. |
| FDA District: | Los Angeles |
| FDA Comments: | Patients should stop using “Lot 8” Quick-set infusion sets.From July 6-9, 2009, the company sent letters to healthcare professionals, distributors, active customers and patients (sets purchased after January 1, 2009) and inactive customers (sets purchased before January 1, 2009). Active patients and customers received one box of replacement sets with their letters.
Letters to patients and customers included instructions to:
Letters to distributors who purchased the affected devices included directions to:
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 either online, by regular mail or by FAX. Useful Links:
Source: FDA Recall Alerts |
Smiths No Longer Shipping Insulin Pump Supplies for Cozmo Pumps
15th May, 2009
Posted Press Release on Smiths Medical Website
Dear Valued Customer,
Important Information for Direct Customers
In late March 2009, Smiths Medical announced that it would no longer manufacture the Deltec Cozmo® insulin pump for direct sale and that we would work with you to transfer your purchases of disposable cartridges, infusion sets and accessories to one of the many national and regional distributors that stock these products.
If you have already transferred your purchases of the Deltec Cozmo® insulin pump cartridges, the Cleo® and Comfort® infusion sets, Cozmonitor® and other items to one of our distribution partners, then please accept my thanks for acting so promptly. If you have not yet moved your purchases to a distributor, then I am writing to advise you that as of 15th June, 2009 Smiths Medical will no longer fill orders from individual pump users for these disposable products. Smiths Medical believes that our customers will benefit from establishing a continuing relationship with a distributor of these disposable supplies.
In order to assist with the transfer of your purchases, I have attached a list detailing all of our distributors that stock our disposable cartridges, infusion sets and accessories. You should contact one of these companies as soon as possible to arrange for your ongoing supplies of these products. Many of these distributors participate directly with a number of health benefits plans around the country, and either the distributor you call or your health plan should be able to help you so that you receive continuing coverage.
As we have previously stated, we will provide you with ongoing support for the remainder of your current pump warranty, and you should continue to call our telephone customer support team at 1-800-826-9703 for any assistance that you require. Furthermore, please be assured that we will continue to make available through our distributors supplies of cartridges, infusion sets and
accessories throughout the lifetime of the warranty on your pump.
If you have any questions about this announcement, please contact our customer support team on 1-800-826-9703. Or, you may visit our web site, www.DeltecCozmoUpdate.com, for more detailed information about Smiths Medical’s recent announcement concerning its Diabetes business.
Yours faithfully,
Richard Thomas
Vice President, Global Diabetes
Smiths Medical
Posted in Diabetes In the News, FDA Alerts, Recalls, Product Safety | Tags: cozmo insulin pumps, smiths medical |
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FDA Deltec Cozmo Insulin Pump Recall
From FDA Enforcement Report April 22, 2009:
Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009;
Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility, Recall # Z-0989-2009
CODE
Product Numbers: 21-1801-51 21-1801-81 21-1803-51 21-1803-81 21-1804-51 21-1804-81 21-1805-137 21-1805-138 21-1805-29 21-1805-49 21-1805-51 21-1805-81 21-1806-137 21-1806-138 21-1806-29 21-1806-49 21-1806-51 21-1806-81 21-1807-137 21-1807-138 21-1807-29 21-1807-49 21-1807-51 21-1807-81 21-1815-01 21-1815-135 21-1815-50 21-1816-01 21-1816-135 21-1816-50 21-1817-01 21-1817-135 21-1817-50 21-1825-81 21-1826-81 and 21-1827-81;
Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul , MN , by letter dated November 20, 2008. Firm initiated recall is ongoing.
REASON
There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what was programmed by the user. In these events, the Pumps delivered the correct amount of insulin as programmed by the user. If the user programs an additional Bolus based solely on the extended Bolus delivered amount displayed on the Bolus Summary Report or Home Screen 2, there is a risk of hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE
17,047 units
DISTRIBUTION
Nationwide and countries of Australia, New Zealand, United Kingdom, Ireland, Canada, China, Greece, Poland, Slovenia, Sweden, Israel and Brazil
Posted in FDA Alerts, Recalls, Product Safety | Tags: cozmo, deltec, fda recalls, insulin pumps, smiths medical |
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