BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 414770 · Received August 28, 2002

    Report

    Report Number
    2939301-2002-09157
    Event Type
    Malfunction
    Date Received
    August 28, 2002
    Report Date
    August 26, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A LIFESCAN METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 213, 169 MG/DL (FIRST SET) AND 328, 232 MG/DL (SECOND SET). TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 20% (FIRST SET) AND 30% (SECOND SET). PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    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 51 YR