BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 598724 · Received June 17, 2004

    Report

    Report Number
    2939301-2004-03632
    Event Type
    Malfunction
    Date Received
    June 17, 2004
    Report Date
    June 9, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTEE THAT THEIR ONE TOUCH ULTRA TEST STRIPS WERE DAMAGED. THERE IS NO FURTHER INFORMATION PROVIDED REGARDING THAT. PATIENT HAD ALSO REPORTED A COMPARISION DONE WITH DIFFERENT RESULTS IN THE FORM OF A RANGE SUCH AS "220-280 AND 140-160. THE TEST STRIPS USED HAD NOT BEEN EXPIRED OR STORED INCORRECTLY. THIS CASE IS REPORTED AS A STRIP MALFUNCTION DUE TO DAMAGED TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2502404

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN