BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 22544188 · Received July 18, 2025

    Report

    Report Number
    3002637618-2025-00055
    Event Type
    Death
    Date Received
    July 18, 2025
    Date of Event
    July 6, 2025
    Report Date
    August 28, 2025
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS COMPLETED. THE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. RAW DATA FILES WERE NOT PROVIDED BY THE CUSTOMER FOR FURTHER ANALYSIS, HOWEVER A REVIEW OF THE CARD LOT PERFORMANCE WAS CONDUCTED. REVIEW OF IN-HOUSE DATA FOR THE CARD LOT UNDER INVESTIGATION IS UNABLE TO CONFIRM THE CUSTOMER¿S OBSERVED ISSUE. REVIEW OF INTERNAL RECORDS DO NOT IDENTIFY ANY OTHER PRODUCTION ISSUES, DEVIATIONS, OR OTHER ESCALATIONS THAT WOULD CAUSE THE CUSTOMER¿S REPORTED ISSUE. NO SYSTEMIC PATTERN ASSOCIATED WITH A SPECIFIC CAUSE WAS OBSERVED. THE CAUSE OF THE CUSTOMER¿S ISSUE REMAINS INDETERMINATE. NO SYSTEMIC PRODUCT PROBLEM IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED MORE INFORMATION AND INSTRUMENT FILES FOR FURTHER INVESTIGATION. INVESTIGATION WILL COMMENCE ONCE INFORMATION HAS BEEN RECEIVED. THE CUSTOMER HAS NOT ALLEGED THAT THE DISCREPANT RESULT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. HOWEVER, SIEMENS IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION DUE TO THE PASSING OF THE PATIENT. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    UPDATE AUGUST 2025: THE CUSTOMER REPORTED DISCREPANT HIGH AND LOW HCO3 (CALCULATED FROM PH AND PCO2) ON A SINCE DECEASED PATIENT THAT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE EXPECTED VALUES CORRESPONDED WITH THE REFERENCE RANGES. THE PATIENT CAME IN FOR PULSELESS ELECTRICAL ACTIVITY ARREST. THERE ARE NO ALLEGATIONS OF UNNECESSARY TREATMENT OR PROCEDURES BEING PERFORMED, NO DELAYED NECESSARY TREATMENTS, AND NO HARM BEING CAUSED RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH HCO3 RESULT OF 12.8 ON A SINCE DECEASED PATIENT THAT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER DOES NOT KNOW IF THE PATIENT WAS TREATED ON THE DISCREPANT RESULT. REPEATED TESTING OF A NEW SAMPLE GAVE A RESULT OF -17.3. THE CUSTOMER HAS NOT PROVIDED WHAT THEIR EXPECTED RESULT WAS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395578 EPOC BLOOD ANALYSIS SYSTEM EPOC READER CHL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Death