BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XE-5000

    MDR report key: 7043310 · Received November 17, 2017

    Report

    Report Number
    1000515253-2017-00041
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 17, 2017
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FACILITY HAS LOOKBACK RULES SET UP IN WAM. THE LOOKBACK RULES WERE WRITTEN BY THE USER TO ONLY RECOGNIZE NUMBERS, NOT TEXT. THE RULE CHECKED AGAINST THE PREVIOUSLY STORED VALUE OF 12 X 10^3/UL, AND SINCE THE PLT VALUES FROM BOTH SAMPLES WERE SIMILAR, WAM CORRECTLY AUTO-VALIDATED THE PLT VALUE OF 23 X 10^3/UL. NO WAM DEFICIENCY WAS IDENTIFIED. THE OPERATOR DISCONTINUED THE LOOKBACK RULE TO PREVENT FUTURE RECURRENCE. USERS ARE INFORMED OF THE SITUATIONS IN WHICH RESULTS MAY BE AFFECTED IN THE XE-5000 IFU CHAPTER 11, POSSIBLE SAMPLE INTERFERENCES. FOR PLATELETS, IT WARNS: "WHERE THE FOLLOWING ARE PRESENT, THE PLATELET COUNT MAY BE REPORTED FALSELY LOW: PLATELET AGGREGATION, PSEUDOTHROMBOCYTOPENIA (INDUCED BY EXPOSURE TO EDTA ANTICOAGULANT), GIANT PLATELETS." A PATIENT SPECIFIC ABNORMALITY CONTRIBUTED TO THIS EVENT. NO ANALYZER DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT SAMPLE, COLLECTED USING EDTA ANTICOAGULANT, HAD A PLATELET (PLT) COUNT OF 12 X 10^3/UL. THE WORK AREA MANAGER (WAM) MIDDLEWARE HELD THE PLT RESULT. THE OPERATOR REVIEWED A SMEAR AND DETERMINED THAT THE PATIENT SAMPLE EXHIBITED PLT CLUMPING IN EDTA ANTICOAGULANT. THE OPERATOR REPLACED THE PLT VALUE IN WAM WITH A COMMENT REQUESTING THAT THE PATIENT SAMPLE BE RECOLLECTED IN SODIUM CITRATE ANTICOAGULANT TO REDUCE PLATELET CLUMPING. WAM STORED THE PLT VALUE OF 12 X 10^3/UL, BUT DID NOT TRANSMIT IT TO THE LABORATORY INFORMATION SYSTEM (LIS). ON (B)(6) 2017, THE PATIENT SAMPLE WAS COLLECTED IN EDTA ONLY, AND A PLT VALUE OF 23 X 10^3/UL WAS GENERATED. THE WAM RESULTS AUTO-VERIFIED AND WERE REPORTED TO THE CLINICIAN. THE PATIENT RECEIVED A PLT TRANSFUSION BASED ON THIS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821890 XE-5000 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other