BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 645018 · Received September 28, 2005

    Report

    Report Number
    2939301-2005-04242
    Event Type
    Malfunction
    Date Received
    September 28, 2005
    Report Date
    September 16, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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

    THE PT CONTACTED LIFESCAN (LFS) IN 2005 ALLEGING THAT THERE WERE BLACK MARKS ON THE CONFIRMATION WINDOW OF THE TEST STRIPS. THE PT HAD THE SAME ISSUE ON THREE DIFFERENT VIALS OF TEST STRIPS. NO INFO ON WHETHER THE VIALS HAD THE SAME LOT NUMBER. SHE ALSO REPORTED BLOOD GLUCOSE RESULTS OF 107, 182, 201 AND 186 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE TEST STRIPS WERE NOT EXPIRED AND THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. CUSTOMER SERVICE SENT THE PT REPLACEMENT TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2586882

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN