BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER

    MDR report key: 12017116 · Received June 17, 2021

    Report

    Report Number
    3002637618-2021-00039
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 8, 2021
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION: THE CAUSE OF THE HEMATOCRIT DISCREPANCY COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED CSV FILES INCLUDING RESULTS FOR ANALYTES OTHER THAN HCT. THE CUSTOMER COULD ONLY PROVIDE RAW DATA FOR FAILED TESTS. WITHOUT RAW DATA (T_FILES) FOR THE ALLEGED DISCREPANT RESULTS, IT IS NOT POSSIBLE TO REACH A CONCLUSIVE CAUSE. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR CARD LOT 10-21060-20 DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THERE WAS NO INDICATION OF DISCREPANT RESULTS AT THE TIME OF PRODUCT RELEASE (FINISHED GOODS TESTING) NOR DURING LIFETIME STABILITY TESTING OR RETAIN LOT TESTING. IN ADDITION, THERE WERE NO OTHER COMPLAINTS RECEIVED ON CARD LOT 10-21060-20. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. SAMPLE HANDLING (SUCH AS COLLECTION VESSEL, MIXING AND METHOD OF COLLECTION) ARE KNOWN TO AFFECT TEST RESULTS IF PROPER PRECAUTIONS ARE NOT CONSIDERED. THE CUSTOMER INDICATED THAT SEVERAL SAMPLES WERE OBTAINED DIRECTLY FROM THE BYPASS MACHINE. IT SHOULD BE NOTED THAT IMPROPER SAMPLE MIXING, INCLUDING SAMPLE COLLECTION FROM A SOURCE WITH A NON-UNIFORM CONCENTRATION CAN CONTRIBUTE TO VARIATION IN TEST RESULTS AND CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS PROVIDED THE EXPECTED RESULTS HOWEVER NO COMPARATIVE TEST WERE RUN. THE CUSTOMER HAS PROVIDED INSTRUMENT FILES AND THE INVESTIGATION IS CURRENTLY UNDERWAY. THE CUSTOMER HAS STATED THAT THEY ARE CURRENTLY OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES DISCORDANT HCT TEST RESULTS WHEN USING THE EPOC READER SN (B)(4). THE CUSTOMER PERFORMED SEVEN READINGS OVER THE COURSE OF A PATIENT'S PROCEDURE, CARDIO PULMONARY BYPASS. THE CUSTOMER IS QUESTIONING RESULTS #3-7. THE CUSTOMER STATED THAT THE EXPECTED VALUE FOR RESULT #3 WAS 19-20%HCT AND THAT THE EXPECTED VALUE FOR RESULT #6 WAS 25-27%HCT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913729 EPOC READER EPOC CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1