BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 598358 · Received April 27, 2005

    Report

    Report Number
    2939301-2005-01821
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Report Date
    April 19, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOT # 250713 OF THE RETAIN STRIPS WAS TESTED AND FAILED. THE TEST STRIPS WERE CUT IMPROPERLY AND ONE OF THE TEST STRIPS HAD A WHITE MARK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN