BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC

    MDR report key: 627234 · Received August 10, 2005

    Report

    Report Number
    2939301-2005-03519
    Event Type
    Malfunction
    Date Received
    August 10, 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 08/2005 THE REPORTER CONTACTED LIFESCAN ON BEHALF OF THE PT ALLEGING THAT THEIR ONE TOUCH BASIC ORIGINAL METER WOULD NOT POWERT ON. THE MEDICAL AFFAIRS SPECIALIST MAILED A LETTER FIVE DAYS LATER AT 11:00 AM SINCE THE PT/REPORTER COULD NOT BE REACHED. THE LAST RESULT WAS OBTAINED ONE DAY BEFORE AT 11:OO AM. THE PT'S PHYSICIAN GAVE THEIR ORAL MEDICATION, ALONG WITH ADVICE ON WHAT TO DO FOR THEIR BLOOD GLUCOSE LEVELS. IT IS UNKNOWN IF THE PHYSICIAN TESTED THEIR BLOOD GLUCOSE LEVEL. IT WOULD HAVE BEEN HELPFUL TO KNOW PT'S BLOOD GLUCOSE LEVEL DURING THE TIME OF CONCERN. THE CUSTOMER SERVICE AGENT VERIFIED THAT THE BATTERY WAS CORRECTLY INSTALLED, THE BATTERY WAS REPLACED LESS THAN ONE YEAR AGO, AND THE BATTERY CONTACTS WERE GOOD CONDITION. THE CSA WALKED THE REPORTER THROUGH PRESSING THE POWER BUTTON AND THE METER DID NOT POWER ON. THERE IS INSUFFICIENT INFO TO SUGGEST THE PRODUCT(S) CONTRIBUTED OR CAUSED SERIOUS INJURY. BASED ON THE FAILED TROUBLESHOOTING, THERE IS AN INDICATIONS THAT THE PRODUCT MEETS THE CRITERIA FOR A MEDICAL DEVICE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC GLUCOSE M ONITORING SYS/KIT CFR LIFESCAN, INC. NA 241976A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR