BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1021416 · Received May 29, 2007

    Report

    Report Number
    2954323-2007-09035
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 29, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 4 WHEN A TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICON APPEARED ON THE DISPLAY OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. ALTHOUGH, THE CUSTOMER DID NOT REPORT 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0634833

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK