BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC HOST

    MDR report key: 10984903 · Received December 10, 2020

    Report

    Report Number
    3002637618-2020-00068
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 10, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708052898
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. THE POC SPECIALIST OBSERVED HOW THE NURSES WERE RUNNING THE BLOOD GASES ON THE EPOC. MANY OF THE NURSES WERE COLLECTING THE SPECIMEN, THEN PUTTING IT ON ICE. THE CUSTOMER STATED THAT IN THE EPOC MANUAL, THE EPOC IS DESIGNED AS A POINT OF CARE DEVICE, AND THE SAMPLE SHOULD NEVER BE PUT ON ICE. THE MANUAL EXPLAINS THAT ICED SPECIMENS CAN ERRONEOUSLY INCREASE THE PH. THE CUSTOMER STATED THAT THE CORRECTION WAS MADE WITH THE ENTIRE NURSING STAFF AND HAS NOT SEEN THE ISSUE OF DISCREPANT HIGH PH SINCE. THE CUSTOMER IS NOT REQUESTING FURTHER ACTION OR INVESTIGATION AND IS ATTRIBUTING THE ISSUE TO NOT PROPERLY TRAINING THE NURSING STAFF.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT HIGH PH RESULTS ON THE EPOC HOST WHEN COMPARED TO RESULTS ON ANOTHER SIEMENS LAB INSTRUMENT, THE RAPID LAB 1265. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450685 EPOC HOST EPOC HOST CGL EPOCAL INC. HH-1009-00-00 00809708052898

    Patients

    Seq Age Sex Outcome Treatment
    1