BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 457803 · Received April 29, 2003

    Report

    Report Number
    2939301-2003-02992
    Event Type
    Malfunction
    Date Received
    April 29, 2003
    Report Date
    April 23, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 04/2003 PATIENT HAD CALLED ALLEGING THAT THE METER WOULD NOT POWER ON. THE CUSTOMER SERVICE REPRESENTATIVE REPLACED PATIENT'S BATTERY, SINCE THE PATIENT HAD NOT USED THE METER IN YEARS. PATIENT CALLED LFS AGAIN IN 04/2003 ALLEGING THAT THE METER HAD MISSING SEGMENTS. PATIENT HAD BEEN ABLE TO POWER THE METER ON USING THE NEW BATTERIES, HOWEVER, THE PATIENT HAD NOTICED MISSING SEGMENTS. IN 04/2003 PATIENT HAD GONE TO THE HOSPITAL (TIME UNKNOWN) AND A READING OF "196 MG/DL" WAS OBTAINED ON THE HOSPITAL METER. NO TREATMENT WAS ADMINISTERED AT THE HOSPITAL. BASED ON THE INFORMATION PROVIDED, THERE WAS NO EVIDENCE OF A SERIOUS INJURY. THE CUSTOMER SERVICE REPRESENTATIVE WALKED PATIENT THROUGH CHECKING THE METER SETTINGS AND THE DISPLAY ISSUE COULD NOT BE RESOLVED. THE METER WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR