BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 439301 · Received January 16, 2003

    Report

    Report Number
    2939301-2003-00482
    Event Type
    Malfunction
    Date Received
    January 16, 2003
    Report Date
    January 13, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF 201, 147, 188 AND 244 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <20% AND/OR <20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION. NOTE: PT REPORTED THAT THEY MAY HAVE TOUCHED THE TEST STRIP WHEN APPLYING THE SAMPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR