BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1780293 · Received July 12, 2007

    Report

    Report Number
    2954323-2007-12531
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEIR FREESTYLE BLOOD GLUCOSE MONITOR WOULD NOT POWER ON PROPERLY, AND THEY ADDITIONALLY REPORTED RECEIVING AN ERROR 4 WHEN A TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICON APPEARED ON THE DISPLAY. ALTHOUGH IT IS UNKNOWN IF THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK