BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC HOST

    MDR report key: 10631223 · Received October 5, 2020

    Report

    Report Number
    3002637618-2020-00053
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 5, 2020
    Report Date
    November 10, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708053901
    PMA / PMN Number
    113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED INSTRUMENT LOGS FROM THE CUSTOMER, HOWEVER THE CUSTOMER HAS NOT PROVIDED THE REQUESTED DATA. THE CAUSE OF THE K+ DISCREPANCIES COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE INHOUSE PERFORMANCE FOR THE CARD LOT USED, LOT 01-20118-10, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT 01-20118-10 IS NOT SHOWING AN INCREASED TREND IN THE FIELD, THEREFORE THERE IS NO FURTHER EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. IT SHOULD BE NOTED THAT SAMPLE HANDLING/DELAYS ARE KNOWN TO AFFECT SAMPLE RESULTS IF PROPER PRECAUTIONS ARE NOT CONSIDERED. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS REQUESTED DATA FILES FOR INVESTIGATION BUT NONE HAVE BEEN PROVIDED. SINCE NO INSTRUMENT FILES COULD BE OBTAINED, LOT PERFORMANCE WILL BE ASSESSED. THE CUSTOMER IS CURRENTLY USING THIS EPOC DEVICE. THE CUSTOMER STATED THE PATIENT IS CURRENTLY STABLE. RESPONSE FROM CUSTOMER: "AFTER MUCH REVIEW AND TESTING, WE HAVE DETERMINED THE DISCREPANCY COULD ONLY HAVE BEEN CAUSED BY PREANALYTICAL ISSUES. IN RUNNING TEN SAMPLES, MY CORRELATION FOR THE POTASSIUM WAS QUITE TIGHT. WE HAVE CONCLUDED THE EPOC WAS NOT RESPONSIBLE FOR THE MI OF THAT PATIENT."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT POTASSIUM VALUES ON THE EPOC HOST WHEN COMPARED TO A NON-SIEMENS LAB INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095327 EPOC HOST EPOC HOST CGL EPOCAL INC. HH-1R09-00-00 00809708053901

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR