BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1060729 · Received June 11, 2008

    Report

    Report Number
    2954323-2008-02085
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 17, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLE TESTING ON THE COMPLAINANT STRIP LOT HAS CONFIRMED A MANUFACTURING ISSUE RESULTING IN ERROR 3 MESSAGES WHEN THESE STRIPS ARE USED WITH FREESTYLE FREEDOM METERS. TESTING CONCLUDED THAT NOT ALL STRIPS IN AFFECTED VIALS ARE IMPACTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 3 MESSAGE WHEN A TEST STRIP WAS INSERTED IN THEIR FREESTYLE FREEDOM METER. 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0703118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK