BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER & POWER SUPPLY

    MDR report key: 12238997 · Received July 28, 2021

    Report

    Report Number
    3002637618-2021-00041
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 23, 2021
    Report Date
    July 28, 2021
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED THE INVESTIGATION: THE IN-HOUSE PERFORMANCE FOR THE CARD LOT IN QUESTION, 01-21087-10, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. CARD LOT 01-21087-10 WAS TESTED WITH ARTERIALIZED BLOOD (HCT ~38%) AND WITH AQUEOUS CONTROL FLUIDS EUROTROL L1 AND EUROTROL L3 AT THE TIME OF PRODUCT RELEASE. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD DISPLAYED NO INDICATION OF DISCREPANT RESULTS AT THE TIME OF RELEASE. RETAIN TESTING WAS ALSO PERFORMED ON CARD LOT 01-21087-10 WITH A BLOOD SAMPLE PREPARED IN-HOUSE TO ACHIEVE A TARGET HEMATOCRIT LEVEL OF ~20-30% TO MIMIC THE CUSTOMER TESTING RANGE. RETAIN TESTING WAS TESTED VS. SPUN HCT AND SHOWED NO INDICATION OF DISCREPANT RESULTS. IN ADDITION, THERE WERE NO OTHER COMPLAINTS RECEIVED ON CARD 01-21087-10. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. NOTE: IT IS POSSIBLE THE METHODS OF HCT MEASUREMENT ARE NOT THE SAME WITH EPOC AND THE COMPARATIVE LABORATORY INSTRUMENT. IT IS UNSURE WHETHER THE COMPARATIVE INSTRUMENT USES A COMPLETE BLOOD CELL COUNT (CBC) METHOD, WHICH HAS KNOWN LIMITATIONS ASSOCIATED WITH THE CALCULATION OF FALSELY ELEVATED VALUES WHEN A HIGH RETICULOCYTE OR WHITE BLOOD CELL (WBC) COUNT IS PRESENT. THIS IS BECAUSE THE HIGHER CELL VOLUMES OF WBCS/ RETICULOCYTES CAN INTERFERE WITH THE RBC COUNT AND THUS FALSELY INCREASE THE HCT READING. THE COMPARATIVE INSTRUMENT PRINTOUT PROVIDED BY THE CUSTOMER INDICATED THE PATIENT'S WBC COUNT WAS FLAGGED AS HIGH, THEREFORE, THE IMPACT/CONTRIBUTION OF THIS MEASUREMENT METHOD CANNOT BE RULED OUT AS A POTENTIAL ELEVATED RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN AND HEMATOCRIT RESULTS FOR ONE PATIENT ON THE EPOC READER WHEN COMPARED 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
    1137786 EPOC READER & POWER SUPPLY EPOC CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1