BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 23497462 · Received November 7, 2025

    Report

    Report Number
    3002637618-2025-00076
    Event Type
    Death
    Date Received
    November 7, 2025
    Report Date
    November 7, 2025
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THE CUSTOMER MENTIONED A PATIENT DEATH WHEN REQUESTING A REVIEW OF INSTRUMENT PERFORMANCE TO AID IN THEIR MORBIDITY AND MORTALITY REVIEW CASE. THE CUSTOMER HAS STATED THAT NO PATIENT TREATMENT WAS PROVIDED BASED ON THE RESULTS OBTAINED FROM THE EPOC INSTRUMENT. THE CUSTOMER IS NOT ALLEGING THAT EPOC CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. NO FURTHER INVESTIGATION TO BE CONDUCTED AS THE CUSTOMER IS UNABLE TO PROVIDE THE REQUESTED DATA. NO PRODUCT PROBLEM FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER REQUESTED A REVIEW OF INSTRUMENT PERFORMANCE TO AID IN THEIR MORBIDITY AND MORTALITY REVIEW CASE. THE CUSTOMER IS NOT ALLEGING THAT THE EPOC INSTRUMENT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. THE CUSTOMER STATED NO CLINICAL DECISIONS WERE MADE WITH THE RESULTS OBTAINED FROM THE EPOC. THE PHYSICIAN HAD A RESULT FROM A DIFFERENT INSTRUMENT WITHIN 10 MINUTES AND THEIR DECISIONS WERE BASED ON THAT ANALYSIS. RESULTS, PATIENT DEMOGRAPHICS, DATE OF EVENT, DEVICE SERIAL NUMBER, AND DETAILS SURROUNDING THE EVENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185549 EPOC BLOOD ANALYSIS SYSTEM EPOC READER CHL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death