BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BGE TEST CARD

    MDR report key: 1235640 · Received November 12, 2008

    Report

    Report Number
    3004959793-2008-00002
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 12, 2008
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Removal / Correction Number
    CAR9037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT ELEVATED POTASSIUM RESULTS OCCURRED OCCASIONALLY ONLY WHEN PERFORMING A BLOOD TEST USING EPOCAL'S EPOC BLOOD GAS AND ELECTROLYTE (BGE) TEST CARD FROM CARD LOT #260 AND THE BLOOD SAMPLE WAS INTRODUCED USING THE PORTEX ARTERIAL BLOOD SAMPLE SYRINGE, MANUFACTURED BY SMITHS MEDICAL ASD, INC. THE ELEVATED POTASSIUM TEST RESULTS OCCURRED DUE TO SAMPLE HEMOLYZATION AT THE BLOOD PORT ENTRY IN THE EPOC BGE TEST CARD. THE SENSORS WERE READING THESE VALUES CORRECTLY. THE EPOC BGE CARD BLOOD ENTRY PORT WAS DESIGNED TO COMPLY WITH ISO594-1: 1986 FOR CONICAL FITTING WITH A 6% LUER TAPER. THE INVESTIGATION DETERMINED THAT THE SMITH'S PORTEX SYRINGE DID NOT COMPLY WITH THE LUER STANDARD, AND HENCE ALLOWED THE SYRINGE TO PENETRATE DEEPER INTO THE BLOOD ENTRY PORT OF THE BGE TEST CARD. THIS PRODUCED A VARIABLE CONSTRAINT IN THE BLOOD SAMPLE FLOW, WHICH OCCASIONALLY RESULTED IN LYSIS OF THE RED BLOOD CELLS (I.E. HEMOLYSIS). AT THE TIME OF THIS REPORT, EPOCAL IS ATTEMPTING TO CONFIRM THROUGH SMITHS MEDICAL THAT SYRINGE IS INTENDED TO COMPLY WITH ISO594-1: 1986.

    Description of Event or Problem · 1

    A POTASSIUM RESULT OF 10.1 MMOL/L WAS REPORTED FROM THE EPOC SYSTEM AT 05:11 IN 2008. AS PER THE FACILITY'S PROCEDURES, THE TEST WAS REPEATED AT 5:20 AND THE POTASSIUM RESULT WAS SUPPRESSED DUE TO AN INTERNAL QUALITY CONTROL FAILURE OF THE EPOC SYSTEM. SINCE THE ELEVATED RESULT WAS NOT CONSISTENT WITH PREVIOUS RESULTS FROM THE EPOC SYSTEM AND DID NOT CORRELATE WITH CLINICAL OBSERVATIONS OF THIS PT, ANOTHER SAMPLE WAS DRAWN AT 05:26 AND THE TEST WAS REPEATED. THE POTASSIUM RESULT WAS THEN 7.6 MMOL/L. AT 07:38 ANOTHER SAMPLE WAS OBTAINED AND THE POTASSIUM RESULT WAS 3.1 MMOL/L ON THE EPOC SYSTEM. THE PT WAS NOT TREATED BASED ON THE ELEVATED POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOC BGE TEST CARD CHL, CEM, JFP, JPI, JGS CHL EPOCAL INC. EPOC BGE TEST CARD 260

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR