BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XN-10

    MDR report key: 6152512 · Received December 7, 2016

    Report

    Report Number
    1000515253-2016-00030
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 5, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DATA PROVIDED DEMONSTRATES ALL INITIAL ANALYSES WERE JUDGED "POSITIVE" WITH MULTIPLE INTERPRETIVE PROGRAM (IP) MESSAGE(S). IN THE ANALYZER'S OPERATOR MANUAL THE USER IS CAUTIONED: A "POSITIVE" OR "ERROR" JUDGMENT INDICATES THE POSSIBILITY OF AN ABNORMALITY. IF A "POSITIVE" OR "ERROR" JUDGEMENT OCCURS, CHECK THE DATA AND REPEAT THE TEST OR EXAMINE CAREFULLY IN ACCORDANCE WITH THE PROTOCOL OF YOUR LABORATORY. IT IS RECOMMENDED TO VERIFY ACCURATE RESULTS PRIOR TO REPORTING TO THE PHYSICIAN. RBC FRAGMENTS/ MICROCYTES WERE NOTED ON THE SMEAR REVIEW UPON LOOK BACK. THE SYSTEM LIMITATIONS AND INTERFERING SUBSTANCES SECTION OF THE OPERATOR'S MANUAL STATES THAT, IF ANY OF THE FOLLOWING IS PRESENT, THE SYSTEM MAY REPORT AN ERRONEOUSLY HIGH PLATELET COUNT: MICROERYTHROCYTES, POSSIBILITY OF FRAGMENTED RBCS, FRAGMENTED LEUKOCYTES, CRYOPROTEIN, AND CRYOGLOBULIN. THE 'FRAGMENTS?' MESSAGE IS DEFINED AS THE "POSSIBILITY OF FRAGMENTED RED BLOOD CELLS" AND IS DETERMINED FROM THE "RBC DISTRIBUTION, PLT DISTRIBUTION, AND RET SCATTERGRAM". NONE OF THE SAMPLES FROM (B)(6) RUN ON THIS PATIENT WERE ANALYZED THROUGH THE RET CHANNEL WHICH ELIMINATED A POSSIBLE MEANS OF DETECTING THE FRAGMENTS OBSERVED. SAMPLES ANALYZED ON (B)(6) WERE ANALYZED THROUGH THE RET CHANNEL UPON WHICH RET ABN SCATTERGRAM AND FRAGMENTS? FLAGS WERE GENERATED. NO EVIDENCE OF ANALYZER MALFUNCTION.

    Description of Event or Problem · 1

    AN INTENSIVE CARE UNIT (ICU) PATIENT HAD MULTIPLE SAMPLES COLLECTED AND ANALYZED FROM (B)(6) 2016. THE PATIENT'S PLATELET (PLT) RESULTS RANGED FROM 51 X 10^3/UL TO 252 X 10^3/UL. ON (B)(6) 2016, A NORMAL PLT VALUE OF 252 X 10^3/UL WAS QUESTIONED BY THE CLINICIAN. A PLT ESTIMATE WAS PERFORMED AND DETERMINED TO BE EXTREMELY LOW. THE OPERATOR THEN REVIEWED PATIENT SAMPLES FROM (B)(6) AND PLATELET ESTIMATES WERE PERFORMED. THE OPERATOR CONFIRMED RBC FRAGMENTS (SHISTOCYTES) / SMALL RBC (MICROCYTES) WERE OBSERVED ON THE SMEAR REVIEWS. THE OPERATOR WAS UNAWARE THE RBC INTERFERENCE WOULD HAVE AN EFFECT ON THE AUTOMATED PLATELET COUNT. THE FALSELY ELEVATED PLT COUNTS WERE DETERMINED TO BE DUE TO A PATIENT SPECIFIC ISSUE. ON (B)(6) 2016, THE PATIENT RECEIVED A PLATELET TRANSFUSION TREATMENT. THE TREATMENT WAS DELAYED DUE TO FALSELY ELEVATED PLT VALUES GENERATED BETWEEN (B)(6) 2016. THIS EVENT WILL BE REPORTED TO THE FDA DUE TO A DELAY IN THE PLATELET TRANSFUSION CARRYING WITH IT THE RISK OF INTERNAL BLEEDING. THERE WAS NO HARM TO THE PATIENT INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803377 XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other