BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 2261549 · Received September 20, 2011

    Report

    Report Number
    3004959793-2011-00002
    Event Type
    Death
    Date Received
    September 20, 2011
    Date of Event
    May 9, 2011
    Report Date
    September 20, 2011
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION ANALYZED THE CUSTOMER FEEDBACK AND CONCLUDED THAT THE K DISCREPANCY BETWEEN EPOC AND VISTA IS LARGELY DUE TO SAMPLE HEMOLYSIS OBSERVED ON THE VISTA. THE INVESTIGATION ALSO ANALYZED THE IN HOUSE DATA BASE, INCLUDING BLOOD AND AQUEOUS RESULTS OBTAINED IN FINISHED GOODS AND LIFETIME STUDIES, FOR INSTANCES OF K CRITICAL MEDICAL ERRORS (CME). THESE ARE INSTANCES WHERE UNACCEPTABLE READINGS FOR K WERE OBSERVED IN TESTING AND NOT FLAGGED BY THE EPOC SYSTEM. (B)(4). NOTE THAT THIS CME OCCURRED IN AN AQUEOUS SAMPLE AND THE BLOOD RESULTS SHOWED NO ISSUES ON LOW POTASSIUM READINGS. THE INVESTIGATION EQUALLY REVIEWED THE PERFORMANCE OF LOT 07-11189-00 IN VARIOUS STUDIES INCLUDING THE FINISHED GOODS AND FOUND IT ACCEPTABLE. WE CONCLUDE THAT THE EPOC SYSTEM ACCURATELY REPORTED THE POTASSIUM LEVEL OF THE SAMPLE THAT WAS USED.

    Description of Event or Problem · 1

    A PT WITH MULTIPLE ISSUES, WAS ADMITTED IN ED ON THE (B)(6) 2011, 13:37 AFTER SHE WAS LAST DIALYZED ON THE (B)(6). BLOOD WAS COLLECTED AT 14:00-14:10 AND SENT TO THE LAB. AT 14:22 AFTER COMING BACK FROM CAT SCAN, SHE STARTED EXHIBITING BUNDLE BRANCH RHYTHM CHANGE AND THE CODE STARTED. AT 14:23, THE SAMPLE REACHED THE LAB. AT 14:25, EPOC REPORTED K=5.1MM. AT 14:45, VISTA REPORTED K=8.1MM WITH A NOTE THAT THE SAMPLE WAS HEMOLYSED. THE PT EXPIRED AT 15:03. THE (B)(6) ED STAFF CONCLUDED THAT "THE PT PROBABLY WOULD NOT HAVE SURVIVED, BUT WITH EPOCAL MISSING THE K+, HAD WE KNOWN IT WAS CRITICAL SOONER, MAY BE SOMETHING COULD HAVE BEEN DONE DIFFERENTLY."

    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 07-11189-00

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death