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FDA Drug & Medical Device Recall News & Comments 
Monday, October 05 2009


Potentially Fatal Errors with Certain Glucose Test Strips

WARNING: 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.

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. See: GDH-PQQ Glucose Test Strip Recall Warning by FDA

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.

FDA RECALL NEWS - Oct. 5, 2009

Posted by: DW AT 01:33 pm   |  Permalink   |  Email
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