BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP

    MDR report key: 3291571 · Received August 1, 2013

    Report

    Report Number
    3291571
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 23, 2013
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    STAFF HAVE REPORTED "PROBLEMS" WITH THE GLUCOSE METERS AND UPON INVESTIGATION WE HAVE DISCOVERED VARIOUS DEGREES OF THE METER BATTERY HEATING AND BULGING TO THE EXTENT OF SPLITTING THE OUTSIDE HOUSING OF THE BATTERY AND RENDERING THE METER UNUSABLE UNTIL WE EXCHANGE THE BATTERY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE INSTRUMENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.IF YOU ANSWERED YES TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:BATTERY HEATING AND BULGING.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:POOR TEST/INSTRUMENT DESIGN.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:MANUFACTURER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361269 STATSTRIP GLUCOSE METER, POINT OF CARE CGA NOVA BIOMEDICAL AS2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *