BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER, HOST

    MDR report key: 10735760 · Received October 26, 2020

    Report

    Report Number
    3002637618-2020-00057
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 19, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS UNABLE TO PROVIDE INSTRUMENT LOG FILES FOR THIS ISSUE. EPOC CALCULATED HGB IS DERIVED FROM THE HEMATOCRIT (HCT) READING ON THE EPOC DEVICE. THEREFORE, THE INVESTIGATION FOCUSED ON HCT PERFORMANCE OF THE CARD LOT 01-20176-40. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT 01-20176-40 DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES FOR HCT. THE FAILURE RATE OF LOT 01-20176-40 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 CAUSE OF THIS EVENT IS UNKNOWN.

    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 CUSTOMER WAS UNABLE TO CONFIRM IF PROPER TECHNIQUE, OR SAMPLE HANDLING WAS USED. THE INSTRUMENT LOG FILES ARE NO LONGER AVAILABLE FOR INVESTIGATION. INVESTIGATION INTO THE PERFORMANCE OF THE TEST CARD LOT IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT THB RESULTS COMPARED TO REPEAT TESTING ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199462 EPOC READER, HOST EPOC CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1