BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 583972 · Received March 15, 2005

    Report

    Report Number
    2939301-2005-01176
    Event Type
    Malfunction
    Date Received
    March 15, 2005
    Report Date
    March 9, 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

    THE PT CALLED ALLEGING ERRATIC READINGS ON THE LIFESCAN METER. THE PT RECEIVED A 215, 241, 359 AND 493 MG/DL. READINGS WERE WITHIN 10 MINUTES OF ONE ANOTHER. THE PT DID NOT SEEK MEDICAL ATTENTION OR CONTACT A PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIPS FAILED USING THE CONTROL SOLUTION TEST TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2536657

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR