BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 2396267 · Received November 28, 2011

    Report

    Report Number
    3004959793-2011-00005
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 28, 2011
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    PMA / PMN Number
    K090109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SINGLE USE TEST CARD IN QUESTION WAS NOT RETURNED. THE ACTUAL TEST DATA FROM THE EPOC DEVICE WAS MADE AVAILABLE. REPRESENTATIVE PRODUCT SAMPLES WERE REQUESTED, BUT HAVE NOT YET BEEN RETURNED FOR EVAL. BASED UPON THE AVAILABLE INFO, THE DISCREPANCY OBSERVED BY THE CUSTOMER WAS AN ISOLATED EVENT THAT OCCURRED ON TWO DIFFERENT BLOOD SPECIMENS COLLECTED IN DIFFERENT COLLECTION DEVICES. AN ASSIGNABLE CAUSE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    (B)(6) HAD A DISCREPANCY IN GLUCOSE VALUES BETWEEN THE EPOC AND KODAK ANALYZER. ON (B)(6) 2011 AT 13:02, THE EPOC REPORTED A GLUCOSE VALUE OF 361 ON A (B)(6) OLD DIABETIC PT. "THE PT WAS TREATED ON THE EPOC RESULTS, HOWEVER, MAINTENANCE OF PT WOULD NOT HAVE BEEN ANY DIFFERENT REGARDLESS. WE GOT THE MAIN LAB RESULTS BACK BEFORE THE INSULIN DRIP WAS STARTED. THERE WAS NO INJURY TO THE PT." A GLUCOSE VALUE OF 946 WAS GIVEN ON THE KODAK FUSION AT 13:43 ON (B)(6) 2011. THE SAME SAMPLE WAS NOT TESTED ON BOTH THE EPOC AND KODAK BUT THE SAMPLES WERE DRAWN AT THE SAME TIME. THE KODAK SAMPLE WAS DRAWN AT 13:08 USING A NEW SYRINGE AND WAS A RIGHT ANTECUBITAL VENOUS SAMPLE THAT WAS PUT INTO A LAB TUBE. THE EPOC SAMPLE WAS DRAWN FIRST. IT WAS A RIGHT ANTECUBITAL VENOUS SAMPLE DRAWN USING A PLAIN 3 CC SYRINGE WITHOUT ANTICOAGULANT. THERE WERE NO PROCEDURES BEING PERFORMED AND THE IV HADN'T BEEN STARTED WHEN THE SAMPLE WAS DRAWN. THE PT'S MOM GAVE THE PT 20 UNITS INSULIN HOME ABOUT 12:15 OR 12:30 ON (B)(6) 2011.

    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 07-11222-00

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other