BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 362489 · Received November 19, 2001

    Report

    Report Number
    2939301-2001-00904
    Event Type
    Malfunction
    Date Received
    November 19, 2001
    Report Date
    October 12, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRECISION TEST: READINGS WERE 162, 325, 189, 210 AND 400 MG/DL WITHIN 10 MINUTES, WITH A DIFFERENCE OF 40%. NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52426 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR