BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 387099 · Received April 2, 2002

    Report

    Report Number
    2939301-2002-04705
    Event Type
    Malfunction
    Date Received
    April 2, 2002
    Report Date
    March 25, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OTP METER, THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 21MG/DL, 134MG/DL, OMG/DL, 149MG/DL, 132MG/DL. TESTS WERE DONE WITHIN LESS THAN 10 MINUTES WITH A DIFFERECE OF 64MG/DL. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE - CUSTOMER USED SEPARATE FINGER STICKS FOR EACH TESTS.

    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 84 YR