Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the skin after injection.
The recalled AccuSure insulin Syringes were distributed to wholesale and retail pharmacies nationwide between January 2002 and October 2009. Anyone who has AccuSure insulin syringes should stop using them. For more information , call Qualitest at 1-800-444-4011.
Video originally created by FDA -- posted by Lawsuit.com on October 6, 2009
FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin, such as Extraneal. A more specific product list can be found below.
The problem is that some glucose meters use a type of test strip (GDH-PQQ) that cannot distinguish between glucose and these other sugars, so the reading on one of these test strips will reflect both the patient’s actual blood glucose and the other sugar the patient received. These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration. This can result in severe hypoglycemia, coma and death. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars.
FDA has received 13 reports of deaths associated with GDH-PQQ test strips that had documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated blood sugar results. Six of the 13 deaths have occurred since 2008, despite previous warnings from FDA and others.
FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.
If a facility does use GDH-PQQ test strips, FDA recommends additional precautions:
• Determine whether patients are receiving products that contain other sugars when they are admitted and periodically during their stay at the facility.
• If patients are receiving one of these interfering products, never use GDH-PQQ test strips to monitor their blood glucose. Instead, use only laboratory-based glucose assays. This also holds true for patients who are unresponsive or cannot communicate adequately.
• Educate the staff about this potentially fatal problem, and consider safeguards such as drug interaction alerts in computer order entry systems, patient profiles and charts. And for patients who are not receiving interfering products, periodically verify glucose meter readings with laboratory-based results.
FDA is working with glucose monitoring manufacturers to address problems with GDH-PQQ glucose test strips, and will continue to monitor adverse events associated with these products.
Video originally created by FDA -- posted by Lawsuit.com on September 3, 2009
In July, Medtronic recalled certain infusion sets which are used with the company’s Mini-Med Paradigm insulin pumps to deliver insulin to diabetic patients. Because of a manufacturing error, the vents on these sets may clog and then fail to equalize the air pressure in the reservoir compartment with the surrounding atmosphere. If this happens, the pump could deliver too much or too little insulin to the patient, and that could lead to serious injury or death.
The recall applies to the MiniMed Paradigm Quick-Set infusion sets with reference numbers MMT-396, MMT-397, MMT-398 or MMT-399 and with lot numbers starting with the number “8.” [Example: 8xxxxxx]. The lot number can be found on both the box label and on each infusion set package.
The firm is advising patients who have the recalled infusion sets to stop using them and to return them to the company for replacement at no additional charge. For more information contact Medtronic at 800-345-8139.
GDH-PQQ glucose test strips produced false high glucose readings that resulted in inappropriate insulin delivery and hypoglycemia, coma and death for some people with diabetes. The FDA gathered fatality reports involving the use of GDH-PQQ glucose test strips to help identify the common risk associated with the test strips.
The risk is specific to people that receive certain therapeutic sugar containing products or non-glucose sugars such as maltose, galactose and xylose. Apparently, the combination of insulin and these products produces a false high reading on the test strip report that triggers diabetics to inject inappropriate levels of insulin. People who are likely to use products that produce the risky sugar combination may be on peritoneal dialysis or have had recent surgery. Though, other people outside of these tow categories may be at risk.
We encourage people to share this information with friends, particularly elders who are less likely to be informed about defective products such as this. Our goal is to broaden consumer awareness to limit personal injury for diabetics. If you or a loved one has been injured by the GDH-PQQ glucose test strips, we encourage you to contact an attorney to learn about your legal rights.
Video originally created by FDA -- posted by Lawsuit.com on July 8th, 2009
Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company’s ACCU-CHEK Spirit insulin pumps.
The defect can cause the “up” and “down” buttons on these pumps to stop working, either completely or intermittently. These buttons are used to change the pump programming or to administer additional insulin through a bolus delivery. So if they do not work, pump users may not be able to change any of the pump’s programmed settings.
When the buttons are pushed, the pump normally responds with a confirmation signal: a sound, a vibration, or both. If the buttons stop working, the signal will not occur, and the pump display will not change. If pump users cannot confirm that a change was made, they should disconnect the pump and switch to a back-up pump or other insulin delivery method. Then they should immediately contact the company’s hotline to get a replacement pump.
If the buttons on the pump continue to work, the company says the pumps can still be used, but users should make sure the “up” and “down” buttons are working, by verifying that they get a confirmation signal after each pump operation.
For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095.
