BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 369715 · Received December 14, 2001

    Report

    Report Number
    2939301-2001-01401
    Event Type
    Malfunction
    Date Received
    December 14, 2001
    Report Date
    November 6, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH ULTRA METER. ON 11/01, PATIENT'S BLOOD GLUCOSE WAS 250, 170 AND 134 MG/DL. TESTS WERE DONE 10 MINUTES APART. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56572 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN