BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC

    MDR report key: 18639550 · Received February 2, 2024

    Report

    Report Number
    MW5151006
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 31, 2024
    Manufacturer
    EPOCAL, INC.
    Product Code
    CEM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EPOC POTASSIUM RESULT OF 11.0MMOL/L AND 11.4MMOL/L ON TWO DIFFERENT SAMPLES COLLECTED APPROXIMATELY 1 HOUR APART ON TWO DIFFERENT EPOC DEVICES. A LABORATORY CMP (COMPREHENSIVE METABOLIC PANEL) WAS COLLECTED AT SAME TIME AS SECOND SAMPLE, THAT SPECIMEN GAVE POTASSIUM RESULT OF 4.9MEQ/L ON HOSPITAL CORE LAB CHEMISTRY ANALYZER. THE LABORATORY REFERENCE RANGE FOR POTASSIUM FOR THIS AGE AND GENDER IS 3.9-6.9 PATIENT HAD AN IV PLACED AND TRANSPORT WAS BEING CONSIDERED UNTIL CORE LAB VALUE WAS REPORTED. BOTH TESTS WERE PERFORMED USING THE SAME CARD LOT, LAB UNABLE TO REPRODUCE EVENT WHILE EVALUATING DEVICES. REFERENCE REPORT: MW5151007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621345 EPOC ELECTRODE, ION SPECIFIC, POTASSIUM CEM EPOCAL, INC. KCC-RMI-AH0-EPOC-READER 03-23243-60

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female