BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZER

    MDR report key: 21361758 · Received February 12, 2025

    Report

    Report Number
    1836135-2025-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 2, 2025
    Report Date
    February 2, 2025
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    CGA
    UDI-DI
    0038193270016
    PMA / PMN Number
    K140068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION OF THE BATTERY COMPARTMENT, PLASTIC CASE DAMAGE INDICATIVE OF IMPROPER/FORCEFUL REMOVAL OF THE BATTERIES WITH A FOREIGN OBJECT WAS OBSERVED. PTS IS CONFIDENT THAT THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE. THE CUSTOMER ALLEGATION OF OVERHEATING WAS OBSERVED NOT OBSERVED ON THE RETURNED ANALYZER. NUMEROUS BATTERY COMPARTMENT IMPROVEMENTS HAVE ALREADY BEEN IMPLEMENTED PRIOR TO THESE ALLEGATIONS FROM THE FIELD. PROCESS IMPROVEMENTS AND PART SPECIFICATIONS HAVE ENHANCED SEATING AND HOLD CAPACITY OF THE BATTERY CONTACTS. ADDITIONALLY, A NEW BATTERY COMPARTMENT DESIGN (APPROVED BY THE FDA PER K193406) ELIMINATES THE POTENTIAL FOR OVERHEATING BY REMOVING THE POINT OF CONTACT THAT AN UNSEATED TERMINAL WOULD REACH.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT "BATTERIES WERE HEATING UP AND THEY COULD FEEL THE COMPARTMENT WAS WARM AND SMELLED A FAINT BURNING." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897609 CARDIOCHEK PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 1.11 0038193270016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown