BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 573909 · Received February 3, 2005

    Report

    Report Number
    2939301-2005-00602
    Event Type
    Malfunction
    Date Received
    February 3, 2005
    Report Date
    January 2, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY MEMBER CONTACTED LIFESCAN ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE FAMILY MEMBER THE NEXT DAY. THE PATIENT OBTAINED RESULTS OF 221, 144, AND 154 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER, WHILE HAVING NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVEL. THEY TOOK THEIR USUAL DAILY ORAL DIABETES MEDICATION (GLUCOPHAGE). THE FAMILY MEMBER CONTACTED THE HOSPITAL FOR ADVICE AND WAS ADVISED THAT THE RESULTS OF 144 AND 154 MG/DL WERE PROBABLY THE TRUE BLOOD GLUCOSE LEVEL. THE PATIENT RECEIVED NO TREATMENT AT THE TIME OF CONCERN. THERE IS NO INDICATION THAT THEY EXPERIENCED INJURY OR MEDICAL INTERVENTION DUE TO THE METER. THE CONTROL SOLUTION WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2521174

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR