BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER

    MDR report key: 8175532 · Received December 17, 2018

    Report

    Report Number
    MW5082217
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    December 12, 2018
    Report Date
    December 14, 2018
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS INC
    Product Code
    MRR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE: CARDIOCHEK PLUS ANALYZER MACHINE WAS TURNED ON FOR BRIEF PERIOD (10 MINUTES OR LESS) AND THEN TURNED OFF. THIS WAS DURING A TRAINING, SO NO PATIENT WAS HARMED. WHILE MACHINE WAS TURNED OFF, IT BEGAN HEATING UP AND BECAME HOT TO THE TOUCH. THE BATTERY COVER WAS OPENED (4 AA BATTERIES ARE USED) AND THE BATTERIES WERE MELTING AND BECAME MOLTEN. THE EMPLOYEE WAS ABLE TO REMOVE THE BATTERIES WITHOUT INJURY, BUT AFTERWARDS THE AA BATTERIES EXPLODED. THIS IS OUR THIRD DEVICE TO OVERHEAT IN 2018, BUT FIRST TIME THAT THE BATTERIES HAVE BECOME MOLTEN AND EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011964 PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN MRR POLYMER TECHNOLOGY SYSTEMS INC
    1011965 PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN MRR POLYMER TECHNOLOGY SYSTEMS INC
    1011966 PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN MRR POLYMER TECHNOLOGY SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention