BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOCAL INC.

    MDR report key: 17577264 · Received August 18, 2023

    Report

    Report Number
    3002637618-2023-00067
    Event Type
    Death
    Date Received
    August 18, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 22, 2023
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED FOR MORE INFORMATION AND DATA FILES FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE CUSTOMER COMPLAINT HAS CONFIRMED A SOFTWARE ISSUE WITH THE EPOC SYSTEM. WHEN A NEW TEST IS RUN WHICH RE-USES THE DATABASE TEST ID OF A PREVIOUSLY RUN TEST THAT WAS DELETED BY THE TEST RETENTION FEATURE, ANY RESULT IN THE DELETED TEST THAT IS NOT AN ANALYTE IN THE NEW TEST WILL BE PULLED IN AND DISPLAYED AS PART OF THE NEW TEST, THIS INCLUDES MEASURED, CALCULATED, AND CORRECTED RESULTS. FROM THE CUSTOMER¿S INFORMATION, IT WAS DETERMINED THAT EACH TEMPERATURE USED TO CALCULATE PH(T), PO2(T), AND PCO2(T) WOULD HAVE HAD TO BE DIFFERENT IF THEY WERE CALCULATED FROM THE MEASURED RESULTS SHOWN IN THE TEST HISTORY SCREEN. WHEN THE CODE WAS EXAMINED, THE CONCLUSION WAS THAT THE TEMPERATURE CORRECTED RESULTS COULD NOT HAVE BEEN CALCULATED FROM THE MEASURED RESULTS SHOWN AT THE TIME OF TEST SINCE THE CODE USES THE SAME TEMPERATURE TO CALCULATE ALL 3 CORRECTED RESULTS. THIS POINTS TO THE FACT THAT THE TEMPERATURE CORRECTED RESULTS DID NOT BELONG TO THAT PATIENT. ALL RESULTS FOR REQUESTED ANALYTES ARE ACCURATE FOR THE PATIENT IN QUESTION. THE CUSTOMER STATED THAT THE EVENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. THIS IS ALSO SUPPORTED BY THE TIMELINE OF EVENTS. THE INITIAL TEST, WHICH CONTAINED THE INCORRECT TEMPERATURE CORRECTED RESULT, WAS RUN ON JULY 6TH AT 20:53. REPEAT TESTING WAS RUN 20 MINUTES LATER AT 21:14 THAT SAME DAY WHICH GAVE A CORRECT RESULT. THE PATIENT RECEIVED A CARDIAC CATHETER PROCEDURE ON THE NEXT DAY, JULY 7TH, AT 15:55 AND A TRANSTHORACIC ECHOCARDIOGRAM AT 18:45. THE PATIENT THEN PASSED AWAY AT 21:04. SIEMENS IS TAKING ACTION TO ADDRESS THIS ISSUE. IT IS ESTIMATED THAT THE PROBABILITY OF OCCURRENCE FOR THIS ISSUE IS LOW AS THERE IS A VERY SPECIFIC SEQUENCE OF EVENTS THAT MUST BE MET FOR THIS SOFTWARE ISSUE TO OCCUR.

    Description of Event or Problem · 0

    THE CUSTOMER IS ALLEGING THAT FOR ONE PATIENT, THE SIEMENS EPOC DEVICE PROVIDED DISCREPANT RESULTS DUE TO INCORRECT APPLICATION OF TEMPERATURE CORRECTION, RESULTING IN DELAY. THE CUSTOMER STATED THAT THE PATIENT DIED LATER. THE CUSTOMER IS NOT STATING THAT THE EPOC DEVICE CAUSED THE DEATH. THE CUSTOMER HAS NOT CONFIRMED ON TYPE OR TIME OF SAMPLE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333623 EPOCAL INC. ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death