BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 587365 · Received March 29, 2005

    Report

    Report Number
    2939301-2005-01354
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Report Date
    March 21, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED BLOOD GLUCOSE RESULTS OF "185 MG/DL" WITH A LIFESCAN METER AND "136 MG/DL" ON A LAB DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. THE TEST STRIPS WERE IN GOOD CONDITION, CODES MATCHED, AND THE TECHNIQUE FOR APPLYING THE BLOOD TO THE TEST STRIP WAS CORRECT. THE METER WAS CLEANED ACCORDING TO THE OWNER'S MANUAL. THE PT PERFORMED A CONTROL SOLUTION TEST, WHICH FAILED. BASED ON THE NFO PROVIDED, THERE IS EVIDENCE OF A METER MALFUNCTION, HOWEVER, THER IS NO EVIDENCE OF THE METER CONTRIBUTING TO A SERIOUS INJURY. A REPLACEMENT METER IS BEING SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH II GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2513674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN