BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZER

    MDR report key: 16112252 · Received January 6, 2023

    Report

    Report Number
    1836135-2023-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 6, 2023
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    CGA
    UDI-DI
    00381932700016
    PMA / PMN Number
    K140068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION, IT IS DETERMINED THAT THE TERMINAL DISPLACEMENT IS MOST LIKELY CAUSED BY THE CUSTOMER PROVIDING UNDUE FORCE ONTO THE BATTERY TERMINALS. IN ADDITION, THE POTENTIAL EXISTS FOR THE BATTERY CONTACT TO LOSE TRACTION WITH THE COMPARTMENT CAUSING LESS FORCE TO DISLODGE HOWEVER IMPROPER REMOVAL OF BATTERIES WILL STILL FORCE THE DISLODGE. SEVERAL KEY FACTORS POINT TO THIS DECISION: THE BATTERY TERMINALS WOULD HAVE TO HAVE BEEN PROPERLY SEATED AT THE TIME OF MANUFACTURING BECAUSE THE ANALYZER WOULD NOT POWER ON AND WOULD CONSEQUENTLY BE UNABLE TO BE CALIBRATED AND RELEASED. 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 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 UPON NEW BATTERY INSERTION THAT THEY AUTOMATICALLY STARTED TO GET WARM AND THEY EXPERIENCED A BURNING SMELL. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536508 CARDIOCHEK PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 2700 00381932700016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown