A voluntary recall of an insulin blood glucose meterused by diabetics and made by Abbott was announced April 15 by the U.S. Food and Drug Administration (FDA) due to a defect causing the meters to give false readings.
The FreeStyle Insulinx® Blood Glucose Meters are sold in the U.S. and numerous countries abroad. The meters were found to give false readings in patients whose blood glucose levels are extremely high ® 1024 mg/dL and above.
Abbott estimates that about 50,000 people are using the meters in the U.S.
The faulty meters displayed and stored in its memory test results that were 1024 mg/dL below the patient’s actual blood glucose level. The recall announcement gave an example of the following: If someone had an actual blood glucose measurement of 1066 mg/dL, the meter would show and store a reading of 42 mg/dL; that is, 1066 mg/dL – 1024 mg/dL = 42 mg/dL.
Abbott said these were the only type of its blood glucose meters that had this flaw.
While blood glucose levels as high as 1024 mg/dL rarely occur, should they actually be that high that patient would be at a serious health risk and would need instant medical care. The misinformation the flawed meter would provide would be much lower than the patient’s actual level of blood glucose. This could delay identifying and treating severe high blood sugar. The false low reading could put a patient at risk of being seriously injured or dying because his or her treatment would be delayed.
In its release, Abbott told users of the FreeStyle Insulinx® Meter to immediately do one of the following:
- Access a software update to solve the problem by going to the Websitewww.freestyleinsulinx.com/swupdate. Consumers can then update their meters to maintain settings and previous data on their meters.
- Contact Abbott Diabetes Care Customer Service to get a return and replacement of their insulin meters for free. Abbott said the meters are in stock and would be delivered as soon as customers asked for them.
The company said patients could continue to use their current FreeStyle Insulinx® until they were updated or replaced, but if the patients’ readings and their symptoms were not in sync, they needed to contact their health care provider.
So far, only one patient in the U.S. and no patients outside the country have been affected by the faulty reading. It is not clear that the problem of the U.S. patient, who was diagnosed with high blood glucose levels and was treated and released, was related to the meter.
Other countries where the device is available are Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Spain, Switzerland, and the United Kingdom. No patient concerns in these countries related to this issue have been reported.
Abbott is an international company involved in developing products and technologies in a wide range of areas of healthcare. The company employs about 70,000 people and sells its products in over 150 countries.
As a product liability and personal injury lawyer, Melinda Helbock represents persons injured by defective and unsafe medical devices throughout San Diego County. She has knowledge of California product liability laws and can help you or a loved one if you have been injured by a defective product. To learn more or to discuss the details of a possible case with Attorney Melinda Helbock, contact our law office today.