BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 361986 · Received November 15, 2001

    Report

    Report Number
    2939301-2001-00791
    Event Type
    Malfunction
    Date Received
    November 15, 2001
    Report Date
    October 5, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRECISION TEST: READINGS WERE 169, 103, 171, AND 93 MG/DL WITHIN 20 MIN WITH A DIFFERENCE OF 28%. NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51795 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR