BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 729105 · Received July 11, 2005

    Report

    Report Number
    2939301-2005-03007
    Event Type
    Malfunction
    Date Received
    July 11, 2005
    Report Date
    July 8, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM.

    Description of Event or Problem · 1

    BLOOD GLUCOSE RESULTS OF "190, 170 AND 122 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2511953

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN