BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZERQ

    MDR report key: 15251475 · Received August 18, 2022

    Report

    Report Number
    1836135-2022-00043
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 18, 2022
    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

    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. 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. 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 THREE DIFFERENT ATTEMPTS THAT THEIR ANALYZER AND BATTERIES WOULD GET HOT TO THE TOUCH RESULTING IN BATTERY DAMAGE. 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
    2461408 CARDIOCHEK PLUS ANALYZERQ CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 0038193270016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown