BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 401715 · Received June 21, 2002

    Report

    Report Number
    2939301-2002-07121
    Event Type
    Malfunction
    Date Received
    June 21, 2002
    Report Date
    June 8, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING AN ERROR 5 ISSUE ON OT ULTRA METER. THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, NOR DID PATIENT RECEIVE ANY TREATMENT. PATIENT ALSO REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH AN OT ULTRA METER. PATIENT'S BLOOD GLUCOSE RESULTS WERE 193, 183, 149, 137, 418, 191, 570, 123, AND 143 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 64%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    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 51 YR