BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 18012534 · Received October 26, 2023

    Report

    Report Number
    3002637618-2023-00087
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 26, 2023
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00630414606095
    PMA / PMN Number
    K200107
    Removal / Correction Number
    3002637618-10-19-2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT CSV FILES, HOWEVER THESE WERE INSUFFICIENT TO BE USED FOR FURTHER INVESTIGATION. HOWEVER, BASED ON THE DETAILS PROVIDED BY THE CUSTOMER, THIS EVENT APPEARS TO BE IN SCOPE OF A CONFIRMED SOFTWARE ISSUE WITH THE EPOC SYSTEM. WHEN A NEW TEST IS RUN WHICH RE-USES THE DATABASE TEST ID OF A PREVIOUSLY RUN TEST THAT WAS DELETED BY THE TEST RETENTION FEATURE, ANY RESULT IN THE DELETED TEST THAT IS NOT AN ANALYTE IN THE NEW TEST WILL BE PULLED IN AND DISPLAYED AS PART OF THE NEW TEST, THIS INCLUDES MEASURED, CALCULATED, AND CORRECTED RESULTS. SIEMENS IS TAKING ACTION TO ADDRESS THIS ISSUE. IT IS ESTIMATED THAT THE PROBABILITY OF OCCURRENCE FOR THIS ISSUE IS LOW AS THERE IS A VERY SPECIFIC SEQUENCE OF EVENTS THAT MUST BE MET FOR THIS SOFTWARE ISSUE TO OCCUR. A FIELD ACTION POC 24-001 "POTENTIAL FOR TEST RECORD TO INCLUDE UNSELECTED ANALYTES" WAS RELEASED ON OCTOBER 19, 2023. CRR # 3002637618-10-19-2023-003-C.

    Description of Event or Problem · 0

    CUSTOMER STATED THAT WHEN PULLING RESULTS ON THEIR NXS HOST HISTORY PAGE FOR A PATIENT TEST WHERE ONLY CREATININE AND EGFR (ESTIMATED GLOMERULAR FILTRATION RATE) WERE RUN, RESULTS FOR OTHER ANALYTES THAT WERE NOT REQUESTED WERE ALSO PRESENTED. THESE RESULTS ARE ALSO SENT TO THEIR DATA MANAGER. CUSTOMER STATED THAT WHILE THE RESULTS WERE POSTED TO THE PATIENT'S CHART, THE PATIENT WAS NOT TREATED BASED ON THE RESULTS THAT WERE INAPPROPRIATELY POSTED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111480 EPOC BLOOD ANALYSIS SYSTEM EPOC NXS HOST CHL EPOCAL INC. 00630414606095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown