BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZER

    MDR report key: 19536414 · Received June 14, 2024

    Report

    Report Number
    1836135-2024-00020
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 14, 2024
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    CGA
    UDI-DI
    00381932702010
    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 WAS DETERMINED THAT THE TERMINAL DISPLACEMENT IS 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, EXTENSIVE PLASTIC CASE DAMAGE AS WELL AS PEN MARKINGS PRESENT THROUGHOUT THE BATTERY COMPARTMENT ARE INDICATIVE OF IMPROPER/FORCEFUL REMOVAL OF THE BATTERIES WITH A FOREIGN OBJECT. THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE. THE CUSTOMER ALLEGATION OF OVERHEATING WAS NOT OBSERVED UPON INVESTIGATION OF THE RETURNED ANALYZER. NO EVIDENCE OF BATTERY "MELTING" WAS OBSERVED. 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 THE BATTERIES IN THEIR CARDIOCHEK PLUS ANALYZER "GOT VERY HOT AND MELTED". 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
    168798 CARDIOCHEK PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 00381932702010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown