BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC READER

    MDR report key: 16667790 · Received April 3, 2023

    Report

    Report Number
    3002637618-2023-00017
    Event Type
    Death
    Date Received
    April 3, 2023
    Date of Event
    February 4, 2023
    Report Date
    June 23, 2023
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS BEEN ASKED FOR MORE INFORMATION AND INSTRUMENT FILES TO COMPLETE INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION. A REVIEW OF THE CUSTOMER AND INTERNAL TEST DATA FOR CARD LOT 04-22296-60, AS WELL AS A REVIEW OF THE PRODUCT SPECIFICATION WAS PERFORMED. THE INVESTIGATION IDENTIFIED A DEFECT IN THE SYSTEM SOFTWARE THAT IS NOT IN-LINE WITH THE TEST CARD AND SYSTEM PERFORMANCE FOR BICARBONATE, CHCO3, AS DESCRIBED IN THE SYSTEM MANUAL. BICARBONATE IS A CALCULATED PARAMETER, MEASURED FROM PCO2 AND PH. THE REPORTABLE RANGE FOR BICARBONATE IS 1 - 85MM. THIS MEANS THAT THE SYSTEM SHOULD BE ABLE TO REPORT OUT CHCO3 RESULTS UP TO 85MM (IN THE ABSENCE OF ANY OTHER ERROR MESSAGES) AND ANY RESULT OVER 85MM WILL BE SUPPRESSED AND DISPLAY ¿OVER REPORTABLE RANGE¿. THE IQC ERROR LIMIT FOR CHCO3 IN THE SOFTWARE IS 75MM, WHICH IS NOT IN-LINE WITH THE REPORTING RANGE OF 1-85MM. IQC LIMITS CAN BE EQUAL TO OR GREATER THAN THE UPPER LIMIT OF THE REPORTING RANGE. THE IQC ERROR IS INTENDED TO SUPPRESS RESULTS WHEN THERE IS A SUSPECTED USER ERROR OR IF SAMPLE INTEGRITY AND ACCURACY CANNOT BE GUARANTEED. BECAUSE THE IQC LIMIT AND REPORTING RANGE FOR CHCO3 OVERLAP, RESULTS BETWEEN 75 AND 85MM HAVE BEEN FALSELY SUPPRESSED (IN THE ABSENCE OF ANY OTHER ERROR MESSAGES). IT SHOULD BE NOTED THAT THE SAMPLE INTEGRITY COULD NOT BE VERIFIED AND SOME PRE-ANALYTICAL ERRORS SPECIFIC TO THIS CASE COULD NOT BE RULED OUT. THIS ISSUE IS CLASSIFIED AS A SOFTWARE DEFECT, THEREFORE, INTERNAL MEASURES ARE BEING TAKEN TO FURTHER INVESTIGATE ROOT CAUSE, RESOLVE, AND ASSESS FOR FIELD ACTION IF REQUIRED. IF A FIELD ACTION IS REQUIRED, IT WILL BE FILED SEPARATELY AS NECESSARY. FOR THE SAME CUSTOMER AND DEATH OF SAME PATIENT, A SEPARATE MDR 3002637618-2023-000018 WAS FILED FOR ANOTHER EPOC DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER IS ALLEGING THAT ONE PATIENT RECEIVED SAMPLING ERRORS ON SIEMENS EPOC DEVICE. THE CUSTOMER STATED THAT THE PATIENT WENT TO THE ER ON FEB 4. LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE HE DIED ON SAME DAY. THE CUSTOMER IS NOT STATING THAT THE EPOC DEVICE CAUSED THE DEATH. THE CUSTOMER HAS YET TO CONFIRM THE TIME THAT THE SAMPLES HAD BEEN RUN AND ON WHICH ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529476 EPOC READER ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death