BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOCAL INC.

    MDR report key: 17493817 · Received August 9, 2023

    Report

    Report Number
    3002637618-2023-00061
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    July 15, 2023
    Report Date
    November 9, 2023
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS REQUESTED FOR MORE INFORMATION AND DATA FILES FOR INVESTIGATION. THE INVESTIGATION COULD NOT PROCEED FURTHER, AS NO DATA FILES COULD BE EXPORTED OR RETRIEVED FROM THE CUSTOMER COUNTRY AFTER 3 REQUESTS. FILES COULD NOT BE PROVIDED DUE TO SANCTIONS AND/OR LIMITED CUSTOMER AVAILABILITY. WITHOUT CUSTOMER RAW DATA FILES, IT IS NOT POSSIBLE TO DETERMINE IF THE E49 ERROR WAS TRIGGERED AS A RESULT OF THE HCO3 VALUE BEING GREATER THAN 75 MM. THERE ARE OTHER REASONS FOR AN E49 OF DISPLAY, THEREFORE THE REASON FOR THE E49 ERROR IN THIS CASE COULD NOT BE VERIFIED. IN THE ABSENCE OF THE INVESTIGATION OF CUSTOMER RAW FILES, THE CERTIFICATE OF ANALYSIS WAS REVIEWED FOR LOT 03-23133-40. THE NRR (NON-REPORTABLE RESULT) RATE ON THE COFA WAS WITHIN THE ALLOWABLE TOLERANCE (4%), THEREFORE THE TEST CARD LOT WAS RELEASED TO FINISHED GOODS. THE CAUSE OF THE EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER IS ALLEGING THAT SAMPLING ERRORS WERE RECEIVED ON SIEMENS EPOC DEVICE WITH NO RESULTS DISPLAYED, FOR ONE PATIENT ONLY. THE CUSTOMER STATED THAT THE PATIENT DIED LATER. THE CUSTOMER IS NOT STATING THAT THE EPOC DEIVCE CAUSED THE DEATH. THE CUSTOMER HAS YET TO CONFIRM TYPE OF SAMPLES AND THE TIME OF SAMPLE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689571 EPOCAL INC. ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death