BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 2398530 · Received November 14, 2011

    Report

    Report Number
    3004959793-2011-00003
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 25, 2011
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR METHOD EVALUATION: RAW DATA FROM TEST RESULTS PROVIDED TO MANUFACTURER (NOT THE ACTUAL TEST CARD). THE DATA ANALYSIS PREFORMED ON IN HOUSE DATA AS WELL AS CLINICAL EDM RESULTS POINTS TO AN ISOLATED NONCONFORMITY WHERE AN INSUFFICIENT SAMPLE (IQC11 ON HCT) PLACED A SAMPLE BUBBLE ON THE TOP OF THE NA MEMBRANE LEADING TO AN UNDETECTED LOW NA READING. ANALYSIS OF CLINICAL DATA OVER THE PAST TWO YEARS SHOWS THAT THE PROBABILITY OF SUCH AN EVENT IS UNDER 250PPM. THEREFORE, EPOCAL (MANUFACTURER) CONCLUDES THAT THIS IS AN ISOLATED NONCONFORMITY.

    Description of Event or Problem · 1

    "(B)(6). AT 0413 ON (B)(6), AN EPOC TEST PANEL WAS RUN ON OUR PT I WILL REFER TO AS "(B)(6)." TEST RESULTS FOR ALL ANALYTES, EXPECT SODIUM, WERE SIMILAR TO THIS PT'S PREVIOUS AND RESULTS. THE SODIUM TEST GAVE A RESULT OF < 85 MMOL/L, HOWEVER. PT CARE STAFF HAVE INDICATED THAT THE SAME SAMPLE WAS SENT TO THE LABORATORY FOR TESTING THAT INCLUDED THE SODIUM TEST. THE LAB'S VITROS F, S PRODUCED A SODIUM RESULT OF 145 MMOL/L SIMILAR TO THE PT'S PREVIOUS AND LATER EPOC TEST RESULTS. THIS DISCREPANCY AND APPARENTLY INACCURATE EPOC RESULT CREATED CONCERN BY PT CARE STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOC BGEM TEST CARD CHL, CEM, JFP, JPI, JGS, CGA, KHP CHL EPOCAL INC. EPOC BGEM 07/11241-00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK