BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1190675 · Received October 6, 2008

    Report

    Report Number
    2954323-2008-02673
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Removal / Correction Number
    2954323-04/28/08-001-C
    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 REPORTED TO THE DISTRICT 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. 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 NI 0703118

    Patients

    Seq Age Sex Outcome Treatment
    1 NI