LifeScan—OneTouch Blood Glucose Meters: May Not Provide Warning at Extremely High Blood Glucose Levels
April 3, 2013 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at email@example.com.
In a March 25, 2013, Urgent Field Safety Notice letter posted by LifeScan and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and a March 25, 2013, Urgent Medical Device Voluntary Recall letter, LifeScan states that the meters below may not operate as intended at extremely high BG levels, potentially leading to incorrect treatment and delayed diagnosis and treatment of extreme hyperglycemia.
For the above OneTouch VerioIQ meters, LifeScan states that, at extremely high BG levels ≥1,024 mg/dL/56.8 mmol/L, the meter may turn off instead of displaying the message "Extreme High Glucose above 600 mg/dL/33.3 mmol/L" as intended. LifeScan also states that when turned back on, the above OneTouch Verio IQ meters will enter the setup mode and require the user to confirm...