BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 517755 · Received January 28, 2004

    Report

    Report Number
    2939301-2004-00588
    Event Type
    Malfunction
    Date Received
    January 28, 2004
    Report Date
    January 27, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "451, 221, 103, 136, 135, 116 AND 115 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 <= 20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN