BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 393056 · Received April 29, 2002

    Report

    Report Number
    2939301-2002-05755
    Event Type
    Malfunction
    Date Received
    April 29, 2002
    Report Date
    April 24, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH ULTRA METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 287MG/DL, 313MG/DL, 148MG/DL, 169MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 35%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE - "CONTROL SOLUTION TESTS: 136, 167, 153(107-145)", THIS INFORMATION WAS PROVIDED IN THE REPORTED ISSUE NOTES.

    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 65 YR