BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 376619 · Received January 30, 2002

    Report

    Report Number
    2939301-2002-00977
    Event Type
    Other
    Date Received
    January 30, 2002
    Report Date
    December 11, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH PROFILE, STRIP NAME: UNK, METER CODE: UNK STRIP CODE: UNK, STRIP STORAGE: UNK, SYMPTOMS: DEHYDRATION, NAUSEA. THE PT REPORTED THAT THEY WERE UNABLE TO TEST. THE METER ALLEGEDLY WAS PROMPTING "NOT OK". THE RESULT FROM THE METER WAS "IN THE 60'S AND 70'S". THERE WERE NO RESULTS REPORTED FROM ANY OTHER SOURCE. THERE WAS NO COMPARISON BETWEEN PT'S METER AND ANY OTHER DEVICE. THERE WAS NO TREATMENT. NO FURTHER INFO HAS BEEN REPORTED.

    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 UNKNOWN Other