BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE METER PLUS

    MDR report key: 1120994 · Received August 16, 2008

    Report

    Report Number
    2027969-2008-00010
    Event Type
    Malfunction
    Date Received
    August 16, 2008
    Date of Event
    June 5, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BIOSITE, INCORPORATED
    Product Code
    KHO
    PMA / PMN Number
    K973547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS RETURNED FOR POWER FAILURE. CUSTOMER SAID, THEY SMELLED BURNING AND BATTERY COMPARTMENT WOULD NOT OPEN. INVESTIGATION FOUND THE BATTERY COMPARTMENT TO BE HARD TO OPEN AND ONCE OPEN, FOUND MAJOR BATTERY CORROSION AND EXPLODED BATTERIES. AREA WAS CLEANED AS WELL AS IT COULD BE AND NEW BATTERIES WERE TRIED. POWER WOULD NOT TURN ON WITH NEW BATTERIES OR KNOWN GOOD POWER SUPPLY. IT APPEARS THE POWER FAILURE WAS CAUSED BY BAD BATTERIES THAT EXPLODED. CUSTOMER MIGHT NOT HAVE CHANGED THEM IN A LONG TIME, AND THEY JUST WENT BAD INSIDE THE METER.

    Description of Event or Problem · 1

    CUSTOMER CALLED ABOUT TRIAGE METER PLUS, STATING THAT THERE WAS A BURNING SMELL IN THE METER AND WOULD NOT FUNCTION PROPERLY. CUSTOMER UNPLUGGED METER, LET SMELL DISSIPATE AND WAS GOING TO DO A POWER RESET, BUT THE BATTERY COMPARTMENT WAS "SEALED SHUT." METER WOULD NOT TURN ON. ALTHOUGH NO INJURY OCCURRED, THERE IS A POTENTIAL IGNITION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE METER PLUS FLUOROMETER KHO BIOSITE, INCORPORATED 55040

    Patients

    Seq Age Sex Outcome Treatment
    1