BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 426215 · Received October 29, 2002

    Report

    Report Number
    2939301-2002-10625
    Event Type
    Malfunction
    Date Received
    October 29, 2002
    Report Date
    October 23, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S METER WOULD NOT DISPLAY THEIR TEST RESULTS CORRECTLY IN THE METER. CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS, NOR DID THEY EXPERIENCE ANY ADVERSE EVENTS. THE METER HAS BEEN REPLACED FOR THE CUSTOMER. A PT REPORTED BLOOD GLUCOSE RESULTS OF 201, 191, AND 132 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINS 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 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR