BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER & POWER SUPPLY

    MDR report key: 11688578 · Received April 19, 2021

    Report

    Report Number
    3002637618-2021-00028
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 19, 2021
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER MULTIPLE REQUESTS FOR INFORMATION BY THE COMPLAINT PREPARER, THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUIRED INFORMATION TO PERFORM AN INVESTIGATION. DCU SHOWED DUE DILIGENCE IN ATTEMPTING TO OBTAIN INFORMATION 5 DIFFERENT TIMES. THE COMPLAINT PREPARER LEFT ADDITIONAL MESSAGES WITHOUT SUCCESS. WITHOUT AN INVESTIGATION, THE ROOT CAUSE CANNOT BE DETERMINED AND THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. SIEMENS RECOMMENDS THAT THE CUSTOMER REVIEW THEIR SAMPLE COLLECTION PROTOCOL AND PRACTICE PROPER SAMPLE HANDLING, AS THIS MAY HAVE A DIRECT IMPACT ON THE HEMATOCRIT. ADDITIONALLY, THE TYPE OF ANTICOAGULANT USED AS WELL AS TESTING DELAYS CAN ALSO IMPACT TEST RESULTS IF NOT PROPERLY CONSIDERED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS. THE CUSTOMER DID NOT PROVIDE THE CARD LOT NUMBER FOR INVESTIGATION. IT HAS BEEN REQUESTED. IF THE CARD LOT IS PROVIDED, THIS ISSUE WILL BE INVESTIGATED BY LOOKING AT IN-HOUSE DATA, FINISHED GOODS TESTING, LIFETIME TESTING, RETAIN TESTING AND A SEARCH TO SEE IF THERE ARE ANY OTHER COMPLAINTS ON THIS SAME CARD LOT. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANT HIGH HEMATOCRIT RESULT WHEN TESTED FOR A TOTAL OF THREE TIMES ON THE EPOC READER AND COMPARED THE RESULT TO A NON-SIEMENS HEMATOLOGY ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584261 EPOC READER & POWER SUPPLY EPOC CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1