BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 586022 · Received March 18, 2005

    Report

    Report Number
    2939301-2005-01219
    Event Type
    Malfunction
    Date Received
    March 18, 2005
    Report Date
    March 17, 2005
    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

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "252, 295, 105, 180, 170, 205, 162, AND 190 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE METER, TEST STRIPS, AND CONTROL SOLUTION ARE BEING REPLACED.

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "252, 295, 105, 180, 170, 205, 162, AND 190 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OR PRECISION. THE METER, TEST STRIPS, AND CONTROL SOLUTION ARE BEING REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR