BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZER

    MDR report key: 23363720 · Received October 22, 2025

    Report

    Report Number
    1836135-2025-00016
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 22, 2025
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    CGA
    UDI-DI
    00381932700016
    PMA / PMN Number
    K140068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. . 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 (OR 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

    THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INACCURATE RESULTS. THE CUSTOMER REPORTED THAT "TWO BATTERIES WERE MELTED TOGETHER AND THEY WERE WARM." CONTACT CONFIRMED THERE WAS NO FLAME/FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777226 CARDIOCHEK PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 1.11 00381932700016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown