BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC HOST

    MDR report key: 10315960 · Received July 23, 2020

    Report

    Report Number
    3002637618-2020-00038
    Event Type
    Death
    Date Received
    July 23, 2020
    Date of Event
    July 2, 2020
    Report Date
    August 14, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708052898
    PMA / PMN Number
    K113726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED INSTRUMENT LOGS FROM THE CUSTOMER, HOWEVER THE CUSTOMER HAS NOT PROVIDED THE REQUESTED DATA. THE CAUSE OF THE MULTIPLE DISCREPANCIES COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT USED, LOT: 10-20082-20, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT: 10-20082-20 IS NOT SHOWING AN INCREASED TREND IN THE FIELD, THEREFORE THERE IS NO FURTHER EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. IT SHOULD BE NOTED THAT SAMPLE CONTAMINATION, IV LINE CONTAMINATION, OR SAMPLE HANDLING ERROR CAN ALL CONTRIBUTE TO MULTIPLE RESULT DISCREPANCIES. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. ALSO STATED WAS THAT THE INITIAL SAMPLE COLLECTED BY THE PARAMEDICS AND RUN ON THE EPOC MATCHED THE NON-SIEMENS LAB ANALYZER RESULTS. SIEMENS REQUESTED T-FILES OR ANY DATA FILES TO BE EXTRACTED FROM THE INSTRUMENT FOR INVESTIGATION. NONE HAVE BEEN RECEIVED TO DATE. UNTIL THEY HAVE BEEN RECEIVED, ONLY THE PERFORMANCE SPECIFICATIONS OF THE LOT PRIOR TO MANUFACTURING RELEASE HAVE BEING REQUESTED. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON ONE PATIENT RUN ON THE EPOC SYSTEM TWICE AND THEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL DUE TO CARDIAC ARREST. THE PATIENT HAD A HISTORY OF ELECTROLYTE ABNORMALITIES. THE PATIENT LATER PASSED AWAY ON THE SAME DAY, (B)(6) 2020. THE CUSTOMER STATED THEY ARE NOT ALLEGING THAT THE EPOC DEVICE ATTRIBUTED TO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779061 EPOC HOST EPOC CGL EPOCAL INC. 00809708052898

    Patients

    Seq Age Sex Outcome Treatment
    1