BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 377679 · Received February 5, 2002

    Report

    Report Number
    2939301-2002-01741
    Event Type
    Other
    Date Received
    February 5, 2002
    Report Date
    January 6, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH PROFILE, STRIP NAME: LIFESCAN, METER CODE: 8, STRIP CODE: 8, STRIP STORAGE: UNKNOWN, SYMPTOMS: NERVOUS. A PATIENT REPORTED THEY WERE SEEN IN ER. THEIR METER ALLEGEDLY WAS INACCURATELY ERRATIC. THE RESULTS ON THEIR METER WERE 25, 319, 388, 405, 400, AND 408 (NO UNITS). THE PATIENT WAS NOT TESTED AT THE ER. THE PATIENT WAS NOT TREATED. THE PATIENT WAS TURNED AWAY BECAUSE THE PATIENT ASKED FOR A BLOOD GLUCOSE TEST WITHOUT ANY TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization