BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1971099 · Received January 26, 2011

    Report

    Report Number
    2954323-2011-01074
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 26, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 1.1 MMOL/L TO 27.8 MMOL/L. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 27.8 MMOL/L. A BLOOD GLUCOSE READING ABOVE 27.8 MMOL/L WILL READ AS A "HI" IN THE ADC METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 50 MMOL/L, 12.6 MMOL/L, AND 8.3 MMOL/L WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL OUT OF RANGE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1013218

    Patients

    Seq Age Sex Outcome Treatment
    1