BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 615505 · Received June 3, 2005

    Report

    Report Number
    2939301-2005-02529
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Report Date
    May 31, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD PERFORMED A PRECISION TEST WITH RESULTS OF 499, 181, 137, 142, 128, 122, 130 AND 125 MG/DL, ALL PERFORMED WITHIN 10 MINUTES OF EACH OTHER. DURING TROUBLESHOOTING, IT WAS VERIFIED THAT THEIR METER WAS CODED CORRECTLY AND THAT THEIR TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRATION DATE. THEY WERE WALKED THROUGH A CONTROL SOLUTION TEST, WHICH FAILED OUTSIDE THE RANGE. THEY WERE ASKED TO RETEST, BUT THE SECOND CONTROL SOLUTION TEST ALSO FAILED. THE PATIENT HAD NOT RECEIVED ANY MEDICAL ATTENTION OR TREATMENT AND THERE IS NO REPORT OF AN ADVERSE EVENT. A REPLACEMENT METER, CONTROL SOLUTION, AND TEST STRIPS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2528696

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR