BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER

    MDR report key: 9741007 · Received February 21, 2020

    Report

    Report Number
    3002637618-2020-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 27, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS FROM THE IN-HOUSE RETAIN TESTING (SENSOR CONFIGURATION 35.N) WERE FOUND TO BE NORMAL AND WELL WITHIN PRODUCT SPECIFICATIONS WITH NO OBSERVABLE IRREGULARITIES IN TESTING OR DURING DATA ANALYSIS. THE EPOC POTASSIUM PERFORMANCE ON CARD LOT 10-19324-30 WAS DEEMED TO BE ACCEPTABLE, WITH NO PRODUCT DEFICIENCIES IDENTIFIED. THE CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER, BUT THERE IS SOME SUGGESTION THAT THE SAMPLE PRESENTED TO THE EPOC SYSTEM MAY HAVE HAD CLOTTING OR MIXING RELATED ISSUES. THE FAILURE RATE OF LOT 10-19324-30 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. SIEMENS HAS REQUESTED THE CARD LOT NUMBER USED, NEEDED FOR INVESTIGATION AND ADDITIONAL INFORMATION TO PROPERLY ASSESS THIS EVENT. ALSO STATED BY THE CUSTOMER IS "NO QC HAS BEEN PERFORMED ON EPOC SINCE 2017". THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT LOW POTASSIUM RESULTS ON THE EPOC READER WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THE CUSTOMER STATED PATIENT TREATMENT WAS AFFECTED: POTASSIUM VIA CENTRAL LINE CATHETER WAS DELIVERED AT A HIGHER DOSE BASED ON THE EPOC RESULT INSTEAD OF DELIVERING A LOWER ORAL DOSE BASED ON THE LAB RESULTS. THE WAS NO REPORTED INJURY TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204999 EPOC READER EPOC CGL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR