BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY PACK

    MDR report key: 965493 · Received December 3, 2007

    Report

    Report Number
    965493
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 27, 2007
    Report Date
    December 3, 2007
    Manufacturer
    VARTA MICROBATTERY, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED WHILE REPLACING A BATTERY IN THE GLUCOSE METER. WHILE A CHARGED BATTERY WAS BEING PLACED INTO METER, THE BATTERY STARTED TO SMOKE AND POPPED OUT OF THE METER. THE BATTERY THEN TURNED BLACK AND CONTINUED SMOLDERING AND SMOKING. UPON INVESTIGATION, THE BATTERY WAS FOUND TO HAVE BURNED A HOLE IN THE COUNTER. THERE WAS NO PATIENT HARM AS A RESULT, BUT THE EMPLOYEE REPORTED BEING BOTHERED BY THE SMOKE FROM THE BURNING BATTERY. HOWEVER, UPON EVALUATION, NO INJURY WAS IDENTIFIED. ALL BATTERIES FROM THIS SAME MANUFACTURER WITH THE SAME DATE WERE REMOVED AND REPLACED. THE MANUFACTURER REQUESTED RETURN OF BATTERY, METER, AND DOCKING STATION FOR ANALYSIS, AND ARE CURRENTLY PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY PACK BATTERY, GLUCOSE METER NBW VARTA MICROBATTERY, INC. 3.7 V 2000 MHH 66380 712 099
    2 STAT STRIP METER, GLUCOSE NBW NOVA BIOMEDICAL 42224 00001L07143

    Patients

    Seq Age Sex Outcome Treatment
    1 *