BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 628695 · Received August 9, 2005

    Report

    Report Number
    2939301-2005-03473
    Event Type
    Malfunction
    Date Received
    August 9, 2005
    Report Date
    August 4, 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

    IN 2005 THE REPORTER CONTACTED LIFESCAN ON BEHALF OF THE PT ALLEGING THAT THEIR ONE TOUCH II METER HAD BROKEN BATTERY CONTACTS. THE PT WENT TO THEIR PHYSICIAN'S OFFICE DUE TO BEING UNABLE TO OBTAIN A BLOOD GLUCOSE RESULT. A RESULT OF 137 MG/DL WAS OBTAINED ON A ONE TOUCH ULTRA METER. THEY REPORTED EATING AND TAKING INSULIN FOLLOWING THE BLOOD GLUCOSE TEST. THE PHYSICIAN ONLY PERFORMED A BLOOD GLUCOSE TEST AND NO TREATMENT WAS ADMINISTERED. THE RESULT OBTAINED BY THE PHYSICIAN WAS NOT SPECIFIED. THE CUSTOMER SERVICE AGENT WAS UNABLE TO CONFIRM IF THE BATTERY WAS DAMAGED OR INSTALLED INCORRECTLY. THE CSA WALKED THE PT THROUGH REPLACING THE BATTERY AND THE METER DID NOT DISPLAY THE BATTERY ICON. THE CSA REPLACED PT'S METER, SINCE THE BATTERY CONTACT WAS BROKEN. THEREFORE, THERE IS AN INDICATION THAT THE METER MEETS THE CRITERIA OF A MEDICAL DEVICE REPORTABLE.

    Description of Event or Problem · 1

    IN 2005 THE REPORTER CONTACTED LIFESCAN ON BEHALF OF THE PATIENT ALLEGING THAT THEIR ONE TOUCH II METER HAD BROKEN BATTERY CONTACTS. THE PATIENT WENT TO THEIR PHYSICIAN'S OFFICE DUE TO BEING UNABLE TO OBTAIN A BLOOD GLUCOSE RESULT. A RESULT OF 137 MG/DL WAS OBTAINED ON A ONE TOUCH ULTRA METER. PT REPORTED EATING AND TAKING INSULIN FOLLOWING THE BLOOD GLUCOSE TEST. THE PHYSICIAN ONLY PERFORMED A BLOOD GLUCOSE TEST AND NO TREATMENT WAS ADMINISTERED. THE RESULT OBTAINED BY THE PHYSICIAN WAS NOT SPECIFIED. THE CUSTOMER SEVICE AGENT WAS UNABLE TO CONFIRM IF THE BATTERY WAS DAMAGED OR INSTALLED INCORRECTLY. THE CSA WALKED THE PATIENT THROUGH RAPLACING THE BATTERY AND THE METER DID NOT DISPLAY THE BATTERY ICON. THE CSA REPLACED PATIENT'S METER, SINCE THE BATTERY CONTACT WAS BROKEN. THEREFORE, THERE IS AN INDICATION THAT THE METER MEETS THE CRITERIA OF A MEDICAL DEVICE REPORTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR