BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 8384067 · Received March 1, 2019

    Report

    Report Number
    3002637618-2019-00025
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    December 4, 2018
    Report Date
    March 1, 2019
    Manufacturer
    EPOCAL INC.
    Product Code
    CDS
    UDI-DI
    00809708032333
    PMA / PMN Number
    K171247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE. SIEMENS REVIEWED THE IN-HOUSE PERFORMANCE OF THE CARD LOT AND WAS FOUND TO BE ACCEPTABLE. THE CUSTOMER IS ADVISED TO CONDUCT A METHOD COMPARISON BETWEEN EPOC AND THE NON-SIEMENS LAB INSTRUMENTS. AS PER THE EPOC USER MANUAL SECTION 12.13.7 D, "BLOOD SAMPLES MUST BE WELL MIXED IN ORDER TO OBTAIN ACCURATE HEMATOCRIT RESULTS". THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN RESULTS ON THE EPOC BLOOD ANALYSIS SYSTEM WHEN COMPARED TO TWO NON-SIEMENS HEMATOLOGY LAB ANALYZERS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177236 EPOC BLOOD ANALYSIS SYSTEM EPOC CDS EPOCAL INC. 00809708032333

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR