BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 18014747 · Received October 26, 2023

    Report

    Report Number
    3002637618-2023-00088
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    July 21, 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
    TX, 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

    THE CUSTOMER ALLEGED THAT THEIR DATA MANAGER PRESENTED ALL RESULTS FOR THE ENTIRE TEST PANEL, AND NOT JUST THE ONES THEY SELECTED WHEN RUNNING THEIR EPOC INSTRUMENT. THE CUSTOMER LATER REPORTED THAT THEIR INSTRUMENT WAS OPERATING AS INTENDED AFTER UPDATING THE CONFIGURATION OF THEIR DATA MANAGER. AT THAT TIME, THIS WAS BELIEVED TO BE AN ISSUE WITH THE DATA MANAGER. ON (B)(6), DURING THE INVESTIGATION OF ANOTHER COMPLAINT, A SOFTWARE ISSUE WAS FOUND. A REVIEW OF THE INFORMATION PROVIDED BY THIS CUSTOMER DETERMINED THAT THIS COMPLAINT WAS IN SCOPE, AND IT WAS THEREFORE RE-ESCALATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434289 EPOC BLOOD ANALYSIS SYSTEM EPOC NXS HOST CHL EPOCAL INC. 00630414606095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown