Diabetic Alert: Blood Glucose Meters Recalled by LifeScan and Abbott Diabetes Care By Tod Aronovitz | 05/08/13 | 0 Comment

LifeScan, a unit of Johnson & Johnson, and the Abbott Diabetes Care division of Abbott have voluntarily recalled blood glucose meters due to malfunctions that may display incorrect test results, especially at extremely high blood glucose levels. Consequently, there may be a delay in the identification and treatment of severe hyperglycemia, or erroneous treatment may be given, leading to potential serious injury or death.

LifeScan OneTouch® Verio® IQ Blood Glucose Meters May Shut Down at Extremely High Glucose Levels

At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch® Verio® IQ Meter will turn off instead of displaying the message “Extreme High Glucose above 600 mg/dL.”

When the meter is turned back on, it starts over in the ‘set-up’ mode, requiring users to insert date and time settings before being able to re-test. Then, the meter shuts off again if the glucose level remains 1024 mg/dL or above.

The recall encompasses 1.2 million OneTouch Verio IQ Blood Glucose Meters sold worldwide (90,000 in the United States), distributed from December 14, 2011 through March 7, 2013. On March 25, 2013, the firm started sending recall notification letters by mail and/or email to consumers, pharmacies, retailers, health care professionals, distributors, wholesalers and mail order distributors.

LifeScan will replace all OneTouch® Verio® IQ Meters at no charge. To receive a replacement meter, call LifeScan Customer Service at 1-800-717-0276 to verify serial number and confirm mailing address.

The current meter may be used until a replacement arrives, but if the device unexpectedly turns off and reverts to set-up mode after being turned back on, blood glucose may be extremely high, and patients should contact their health care professionals for treatment.

Abbott FreeStyle lnsulinx® Blood Glucose Meters May Provide Inaccurate Readings at Extremely High Blood Glucose Levels

Even though blood glucose levels at 1024 mg/dL and above tend to be rare, Abbott determined that at those extreme levels, its FreeStyle lnsulinx® Meter will display and store in memory an incorrect test result. No other Abbott blood glucose meters have this issue.

The incorrect results that appear on the FreeStyle lnsulinx® meter have been found to be 1024 mg/dL below the actual measured result. For example, at an actual blood glucose value of 1066 mg/dL, the meter will instead display and store a value of only 42 mg/dL.

Abbott has provided a software update to resolve this issue and allow customers to maintain settings and historical data on their meters. In addition, Abbott will send replacement FreeStyle lnsulinx® meters at no charge to customers who have purchased them. For more information, call Abbott Diabetes Care Customer Service at 1-866-723- 2697.

Until updated software is loaded or until a requested replacement meter arrives, the current FreeStyle lnsulinx® meter may be used. However, the company cautions if customers’ symptoms don’t match their readings, they should contact their healthcare professionals and follow treatment advice.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of both of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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