BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1061072 · Received June 13, 2008

    Report

    Report Number
    2954323-2008-02112
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    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. THIS ISSUE IS ASSOCIATED WITH FIELD CORRECTION 2954323 REPORTED TO THE OFFICE ON 25 APR 2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 3 MESSAGE WHEN A TEST STRIP WAS INSERTED IN THEIR FREESTYLE FREEDOM METER. THE CUSTOMER REPORTED USING THE AFFECTED TEST STRIPS AT THE TIME THE ERROR 3 MESSAGE WAS RECEIVED; HOWEVER, THE AFFECTED TEST STRIPS WERE DISCARDED PRIOR TO THE CALL.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. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI