BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 21433223 · Received February 21, 2025

    Report

    Report Number
    3002637618-2025-00011
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 26, 2025
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708116712
    PMA / PMN Number
    K200107
    Removal / Correction Number
    3002637618-03-19-2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED THE OCCURRENCE OF DISCREPANT HIGH PH RESULTS IN SAMPLES INTRODUCED WITH HIGHER INJECTION VOLUMES (BEYOND THE EPOC READER BEEP OR AFTER THE "ANALYZING SAMPLE" MESSAGE IS DISPLAYED) WITH EPOC SENSOR CONFIGURATION 45.N (SOFTWARE VERSION: EPOC HOST V3.41.2 AND EPOC NXS V4.14.9 & 4.14.11). IT SHOULD BE NOTED THAT TOTAL CARBON DIOXIDE (TCO2) IS A MEASURED VALUE THAT USES THE PH RESULT AND THAT DISCREPANT HIGH PH RESULTS MAY AFFECT THE FOLLOWING CALCULATED VALUES: ANION GAP (AGAP) (THROUGH CHCO3 OR TCO2), BASE EXCESS (BLOOD) (BE (B), BASE EXCESS (EXTRA CELLULAR FLUID) (BE (ECF)), CALCULATED BICARBONATE (CHCO3-), CALCULATED OXYGEN SATURATION (CSO2), CALCULATED TOTAL CARBON DIOXIDE (CTCO2). SIEMENS HEALTHCARE DIAGNOSTICS DETERMINED THE ROOT CAUSE OF THE PH BIAS TO BE CAUSED BY SENSOR CONFIGURATION 45.N. SIEMENS HAS RELEASED A NOTIFICATION "DISCREPANT HIGH PH RESULTS WITH SENSOR CONFIGURATION 45.N" TO INFORM CUSTOMERS OF THE ISSUE AND PROVIDE A WORKAROUND OPTION. CRR#: 3002637618-03-19-2025-001-C.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT FILES. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT HIGH PH ON ONE PATIENT WHEN COMPARED TO REPEAT TESTING ON A NEW EPOC INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692849 EPOC BLOOD ANALYSIS SYSTEM EPOC READER CHL EPOCAL INC. 00809708116712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown