BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 627005 · Received August 10, 2005

    Report

    Report Number
    2939301-2005-03511
    Event Type
    Malfunction
    Date Received
    August 10, 2005
    Report Date
    July 8, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "220, 101, 135, AND 141 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. HOWEVER, THE PT WAS NOT CLEANING THE PUNCTURE SITE CORRECTLY WHICH CAN AFFECT RESULTS. THE PT ALSO REPORTED THAT THE TEST STRIPS WERE "STICKING TOGETHER". BECAUSE THE TEST STRIPS REPORTEDLY WERE STICKING TOGETHER IN THE VIAL, THE COMPLAINT IS BEING REPORTED AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2566258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN