iPump, Inc.

Archive for the ‘FDA Alerts, Recalls, Product Safety’ Category

I was recently contacted by a concerned representative from Medtronic MiniMed.  The representative (whose name I will not use) asked me to pass along the following information for Medtronic pump users who may have recalled infusion sets.  Her post indicates Medtronic was deeply concerned about the safety of their clients and the company caught the problem before any adverse events occurred.  I felt it only fair to allow Medtronic to respond to my previous posts voicing my own concerns, using their own words:

Thank you so much for the conversation today.  I’m enclosing the link you can place on your website to inform folks that Lot 8 Quick-sets have been recalled.  It contains instructions of what to do with them and background information.

One thing to note is that the Lot 8 situation was discovered by Medtronic through an employee with diabetes, and not through any patient adverse events. When that occurred, we assessed the situation as quickly as possible, worked with our medical advisors, changed the manufacturing process, and contacted the FDA about the voluntary recall.  We distributed the recall letters along with a supply of corrected infusion sets so that patients had the products they needed right away, and asked them to return their product (the process for doing so it documented on our website).  We also sent a follow up note from our then-president, Chris O’Connell to customers (we have a new president now and her name is Katie Syzman – she’s the first female president at Medtronic, which is very nice).  From an inside perspective, there was a lot of care and compassion from our employees who worked hard do the right thing and act quickly for our customers.  There were many late nights during the month of July!

The website link for more information about what to do with any recalled infusions sets is http://www.medtronicdiabetes.com/lot8/

FDA Drug Safety Alert:

Sitagliptin (marketed as Januvia and Janumet) – acute pancreatitis.

Audience: Diabetes healthcare professionals, patients

[Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.

Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.

Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.

[09/25/2009 - Information for Healthcare Professionals - FDA]

Source:  FDA Website

Januvia is used in the treatment of type 2 diabetes and acts to help lower blood glucose levels.

Last year, a national guideline-setting group abruptly withdrew a controversial diabetes standard it adopted in 2006 that called for aggressive control of blood sugar, or glucose. The change came after a large federal study indicated that lowering glucose too quickly or too much in some patients could harm or even kill them.

When I read the above in an article appearing in the health section of the New York Times website, I was stunned. It also made sense! My doctor insisted on such tight control over my daughter’s type 1 diabetes I refused to follow his advice knowing it would be her life on the line. Specifically, I was instructed to correct her anytime she was over 180. That might sound reasonable, except he specifically said to correct her even one hour after eating when she would still have insulin board working in her system. Had I done this she would have crashed to the floor every single time.

Perhaps her former endo was one of the doctors paid to promote these guidelines!

Source: New York Times. Diabetes Case Shows Pitfalls of Treatment Rules. August 18, 2009.

By now all Cozmo insulin pump users should have heard that Smiths Medical is no longer providing pump supplies to Cozmo pumpers.  Here is a list of places where you can still find supplies:

Smiths Medical FAQs for Cozmo Insulin Pump Users

List of United States Distributors of Insulin Pump Supplies Compatible with Cozmo Insulin Pumps
(From Smiths Medical)

American Home Patient
5200 Maryland Way, Ste 40
Brentwood, TN 37027 203-596-8949 203-596-8940

CCS Medical/DEGC
14255 49th St N, Ste 301
Clearwater, FL 33762 800-726-9811 727-507-2383

Diabetes Management & Supplies
10 Commerce Ct, Ste B
New Orleans, LA 70123 888-738-7929 504-734-7164

Diabetes Specialty Center
735 E 33005 S
Salt Lake City, UT 84106 801-268-9699 801-587-3669

Diabetes Supply Center of the Midlands
2910 S 84th St
Omaha, NE 68124 800-779-3374 x 216 402-399-8616

Diamond Diabetic – DDP Medical Supply
11800 28th St N
St. Petersburg, FL 33716 800-437-4455

Direct Diabetes Supply
13402 N Scottsdale Rd, Ste A125
Scottsdale, AZ 85254 480-998-5551 480-998-5247

Direct Healthcare Supply
5640 Hudson Industrial Pkwy, Box 309
Hudson, OH 44236 888-344-3434 x7312 877-753-3033

Doubek Medical Supply
11350 S Cicero Avenue,
Alsip, IL 60803 708-293-1122

Edgepark Surgical
1810 Commerce Park
Twinsburg, OH 44087 800-321-0591 330-963-8576

Gemco
5640 Hudson Industrial Pkwy
Box 429
Hudson, OH 44236 800-733-7976 330-342-9444

Great Lakes Home Healthcare Services
1647 Sassafras St
Erie, PA 16502 814-877-4662 814-877-5260

Great Lakes Medical Supply
23247 Pinewood Street
Warren, MI 48091 800-774-0788

Independence Medical
1810 Commerce Park
Twinsburg, OH 44087 800-860-8027 330-963-0709

J & B Medical Supply
50496 W Pontiac Trail
Wixom, MI 48393 248-892-6201

JQ Medical Supply
2370 Fort Union Blvd
Salt Lake City, UT 84121 801-942-8582 x 107 801-942-8069

Liberty Medical Supply
2157 Apperson Dr,
Salem, VA 24153 877-922-7867 x 1402 540-777-0001

Medical Services of America/MedExpress
171-B Monroe Ln
Lexington, SC 29072 800-381-6339 x 6745 866-856-6339

Medical Pumps & Supplies
PO Box 1480
Johnson City, TX 78636 830-868-7712 830-868-7027

Mini Pharmacy
2425 Porter Street
Los Angeles, CA 90021 213-622-3966

Nations Health–Diabetes Care and Education
13650 NW 8th Street
Sunrise, FL 33325-6239 888-388-4622 502-657-0237

Neighbohood Diabetes
15 Commonwealth Avenue
Woburn, MA 01801 866-784-5647 866-784-5646

Option Care
100 Corporate N
Ste 212
Bannockburn, IL 60015 800-456-0417 573-814-7112

Pal-Med
PO Box 2538
West Columbia, SC 29171 803-794-0369 803-791-9019

Providence Home Services – Portland
1310 NE 44th Ave
Portland, OR 97213 503-215-4900 503-215-0691

Pumps It
10601 Grant Rd, Ste 215
Houston, TX 77070 281-955-8900 281-955-8992

Solara Medical Supplies
990 Highland Dr
Ste 107
Solana Beach, CA 92075 619-424-8143 702-796-0818

Star Discount Pharmacy
704 Pratt Ave
Huntsville, AL 35801 256-534-1118

The following is an excerpt updating the status of proposed legislation prompted by a lawsuit against Medtronic in which consumers lost.

From: Medtronic Lead Recall Center

…”On August 04, 2009 there was a hearing on S. 540: the Medical Device Safety Act of 2009. This legislation would reverse the 2008 Riegel Supreme Court decision and allow patients injured by medical devices the right to bring a claim for compensation. This legislation would also help remove harmful medical products from the market even if they were initially approved by the FDA. Class III medical devices include heart defibrillators, artificial valves, and prosthetic knees and hips.

Note: The 2008 Riegel Supreme Court decision denied patients who died or were injured by medical devices the right to bring a claim for compensation. In particular, Medtronic was not found liable for tort damages (such as pain and suffering, emotional distress, etc.) and therefore has continued to confidently offer a variety of medical devices with known defects – because of the limitations on how people could sue.

Our concern is this: If a client was injured or died as a result of an insulin pump improperly recertified by Medtronic, our client would have very little legal recourse against the company. While this would be true of any insulin pump manufacturers, it is the overall way in which Medtronic conducts business and the number of lawsuits against them for faulty medical devices that causes us concern.

…”Currently, the medical device industry enjoys complete immunity for their class III medical devices, even when the devices are found to be defective and dangerous, and have even been recalled. This benefits all patients by helping make sure that safe medical products are in the marketplace. The Medical Device Safety Act is vitally important for victims of defective Medtronic defibrillator leads who are currently left without any meaningful legal options and patients in general who use FDA approved medical devices.

More Information
Medtronic Class Action Lawsuits

Note: We are not in any way associated with, connected with, or receive any compensation or donations from the Medtronic Lead Recall Center. We merely capture and highlight this law firms news updates.