BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 422913 · Received April 15, 2002

    Report

    Report Number
    2939301-2002-05262
    Event Type
    Malfunction
    Date Received
    April 15, 2002
    Report Date
    April 7, 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

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OT ULTRA METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 280, 140, 160, 130MG/DL. (METER). TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 41%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE - CUSTOMER WAS NOT USING THE SAME FINGER USED SEPARATE FINGER STRIPS. ONE BOTTLE OF STRIPS WAS NOT FALLING WITH RANGE. A NEW BOTTLE OF TEST STRIPS TESTED 121, 136 (111-150) IT AS WELL AS TESTED THE OTHER BOTTLE OF STRIPS USED ON THE 2ND METER AND IT WAS WITHIN RANGE 137, 146 (111-150).

    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 60 YR