BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC HOST

    MDR report key: 10286296 · Received July 16, 2020

    Report

    Report Number
    3002637618-2020-00034
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708052898
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE CAUSE OF THE CHGB DISCREPANCY COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT USED, LOT 01-20029-20, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT 01-20029-20 IS NOT SHOWING AN INCREASED TREND IN THE FIELD, THEREFORE THERE IS NO FURTHER EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. THE CUSTOMER'S INSTRUMENT IS NOT CURRENTLY IN USE AS IT WAS RETURNED IT TO THE REPAIR FACILITY. THE CUSTOMER RECEIVED A REPLACEMENT AND IS OPERATIONAL WITH A NEW INSTRUMENT AT THIS TIME. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE EPOC HOST WHEN COMPARED TO A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745799 EPOC HOST EPOC HOST CGL EPOCAL INC. 00809708052898

    Patients

    Seq Age Sex Outcome Treatment
    1