BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

    MDR report key: 5494204 · Received March 10, 2016

    Report

    Report Number
    1000515253-2016-00006
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    February 7, 2016
    Report Date
    February 9, 2016
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER IS ULTIMATELY RESPONSIBLE FOR WORKFLOW AND FOR USING SYSMEX INSTRUMENTATION AND MIDDLEWARE ACCORDING TO DIRECTIONS. IF THIS SITUATION WERE TO RECUR, THE CHANCE OF HARM TO THE PATIENT IS MINIMAL. THE USER ALSO IS RESPONSIBLE FOR FOLLOWING CORRECT PROCESS, SO THAT ACCURATE RESULTS ARE ATTACHED TO THE SAMPLE COLLECTED AND ANALYZED THAT DAY. IT IS UNLIKELY THAT A PHYSICIAN WOULD BASE CLINICAL DECISIONS UPON RESULTS ALONE WITHOUT CONSIDERATION OF OTHER CLINICAL SIGNS AND SYMPTOMS. THE ERRONEOUS RESULT WAS AUTO-VALIDATED BY WAM; AUTO-VALIDATION IS BASED ON A RULE ENGINE THAT APPLIES RULES LOGIC TO DETERMINE WHETHER RESULTS ARE NEGATIVE OR POSITIVE. IF ONE RULE IS TRIGGERED ON THE ORDER FOR A SAMPLE ID, THE RESULTS ARE NOT AUTO-VALIDATED AND REQUIRE MANUAL REVIEW BY THE TECHNOLOGIST. THE USER SUBMITTED A "REQUEST CHANGE FORM" TO MODIFY THE RULES TO ACTIVATE ON ALL RUNS. THE SOFTWARE TECHNICAL SPECIALIST CREATED NEW RULES SO THAT PLT RESULTS WILL HOLD AND REFLEX PLT-O IF THERE IS PREVIOUS PLT REPORTED AS "CPL - "NOT DONE DUE TO IN VITRO CLUMPING IN EDTA" IN LAST 7 DAYS. THE RULES HAVE BEEN TESTED AND MOVED TO PRODUCTION. WHILE THE USER ULTIMATELY IS RESPONSIBLE FOR PROPER COLLECTION OF PATIENT SAMPLES AND RESULTS AND REPEAT COLLECTION AND TESTING WHEN INDICATED, THIS ISSUE WILL BE REPORTED ON THE BASIS THAT INCORRECT RESULTS LED TO A PATIENT RECEIVING AN UNNECESSARY TRANSFUSION, CARRYING WITH IT THE RISKS INVOLVED WITH RECEIVING BLOOD PRODUCTS: TRANSFUSION REACTION, DEVELOPMENT OF ANTIBODIES, ETC.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE USER OF A SYSMEX WORK AREA MANAGEMENT (WAM) MIDDLEWARE REPORTED THAT A PLATELET (PLT) RULE DID NOT TRIGGER TO HOLD CRITICAL LOW PLT RESULTS FOR SAMPLE ID (SID) (B)(6). THE PLT COUNT FOR SID (B)(6) WAS FALSELY DECREASED DUE TO PLATELET CLUMPING. THE PLT RESULT OF 22 X10^3/¿L (NORMAL RANGE: 150-400 X10^3/¿L) AUTOVERIFIED. THE PATIENT RECEIVED AN "UNNECESSARY" PLT TRANSFUSION. PREVIOUS NUMERIC PLT TEST RESULTS ANALYZED ON (B)(6) 2015 WERE ALSO AFFECTED BY PLATELET CLUMPING. THE NUMERIC RESULTS WERE REPLACED BY THE OPERATOR WITH A NON-NUMERIC PLT RESULT OF "CLP" THAT INDICATES THE TEST WAS "NOT DONE DUE TO IN VITRO CLUMPING IN EDTA." WHEN THE PLT ANALYSIS ON (B)(6) 2016 HAD A PLT= 22 X10^3/¿L, THE USER EXPECTED A PLT RULE IN THE WAM TO HOLD THE RESULTS FOR SID (B)(6). THE PLT RULE DETERMINES WHETHER A DELTA CHECK WAS TRIGGERED TO APPLY THE LOOKBACK CODE WITHIN THE LAST 7 DAYS. THE RULE DID NOT EXECUTE ON SID (B)(6) BECAUSE THERE WAS A PREVIOUS OCCURENCE OF PLT=22 ON SID (B)(6) WITHIN 7 DAYS THAT TRIGGERED THE LOOKBACK CODE. THE PLT RESULT OF 22 X10^3/¿L WAS RELEASED TO THE ATTENDING PHYSICIAN. THE FACILITY'S CRITERIA FOR A PLT TRANSFUSION IS A PLT RESULT LESS THAN 30 X10^3/¿L. THE ATTENDING PHYSICIAN ORDERED A PLT TRANSFUSION BASED ON THE PLT RESULT. THE OPERATOR PERFORMED A PLT ESTIMATE FROM EXAMINATION OF A MANUAL SMEAR, AND ESTIMATED THE PLT COUNT WAS 100 X10^3/¿L. WHILE REVIEWING THE PATIENT'S HISTORY, THE CLINICAL LABORATORY SCIENTIST (CLS) NOTED THAT THE PATIENT HAS A HISTORY OF PATIENT CLUMPS. WHEN PLT CLUMPS ARE PRESENT THE PLATELET COUNT MAY REPORT FALSELY LOW. THE USER REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE PLATELET TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149588 SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS) MIDDLEWARE OUG SYSMEX AMERICA INC. WAM V.4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other