FDA MedWatch - LifeScan, Inc.OneTouch Verio IQ Blood Glucose Meter - Recall: Failure to provide a warning at extremely high blood glucose levels

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - LifeScan, Inc.OneTouch Verio IQ Blood Glucose Meter - Recall: Failure to provide a warning at extremely high blood glucose levels

LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: 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” as intended. When turned back on, the meter enters the “Set-Up” mode and requires the user to confirm the date and time settings before being able to test again. However, if the glucose level is still measuring1024 mg/dL or above when testing, the meter will shut down again.

BACKGROUND: The OneTouch Verio IQ Blood Glucose Meter is an over-the counter single-use device intended to be used by a patient outside of a health care facility as an aid to monitor the effectiveness of diabetes control measures sugar (glucose) in blood drawn from the fingertips. All OneTouch Verio IQ Blood Glucose Meters are being recalled and were distributed from December 14, 2011 through March 7, 2013.

RECOMMENDATION:

If the OneTouch Verio IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, blood glucose may be extremely high, and you should call your health care professional.  Call LifeScan Customer Service at 1-800-717-0276 for support.

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

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349187.htm

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