BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XE -5000 ANALYZER

    MDR report key: 4329693 · Received November 3, 2014

    Report

    Report Number
    3009711478-2014-00023
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 31, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING 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. THE HOST LOG FOR THE EVENTS ON (B)(6) 2014 FROM THE HOST COMPUTER SHOWS SID (B)(6) WAS NOT RECEIVED FOR TESTING UNTIL 07:54; THEREFORE, THERE WERE NO RESULTS FOR SID (B)(6) AT THE TIMES SID (B)(6) WAS ANALYZED AND REPEATED. THE USER CONFIRMED THE EVENT WAS DUE TO AN OPERATOR ERROR. THE USER REPORTED THAT THEY WORKED WITH THEIR QUALITY ASSURANCE DEPARTMENT TO IMPLEMENT THE FOLLOWING CHANGES TO HELP ELIMINATE THIS FROM HAPPENING IN THE FUTURE: THEY WILL RESTRICT THE ABILITY OF THE OPERATOR TO EDIT SAMPLE IDS. EACH OPERATOR WILL BE ASSIGNED THEIR OWN LOG ON. EAC OPERATOR WILL COMPLETE THEIR OWN WORK; THERE WAS A HANDOFF SITUATION WITH HIS SCENARIO.

    Description of Event or Problem · 1

    THE USER OF A XE-5000 AUTOMATED HEMATOLOGY ANALYZERS (SERIAL NUMBER (B)(4)) REPORTED THAT BASED ON ERRONEOUS LOW HGB RESULT OF 8.4G/DL, PATIENT WITH SAMPLE ID (SID) (B)(6) WAS UNNECESSARILY TRANSFUSED, WITH TWO UNITS OF PACKED RBCS. SID (B)(6) WAS ANALYZED ON (B)(6) AT 07:43 USING THE AUTOMATIC MODE; THEREFORE, THE SAMPLE'S BARCODE WAS READ BY THE ANALYZER'S INTERNAL BARCODE READER. THE OPERATOR RERAN THE SAME SAMPLE AT 07:48 USING THE MANUAL MODE; THE SID WAS ENTERED BY THE OPERATOR. ACCORDING TO THE HOST'S LOG THE OPERATOR INCORRECTLY MODIFIED SID (B)(6); BECAUSE THE OPERATOR MODIFIED THE SID THE WRONG RESULTS TRANSMITTED TO SID (B)(6); THUS, THE WRONG RESULTS REPORTED OUT OF THE LABORATORY. THE ONLY RESULTS SUBMITTED FOR SID (B)(6) WAS RUN ON (B)(6) AND A HGB RESULT OF 12G/DL WAS OBTAINED; IT IS UNKNOWN IF THERE ARE ANY OTHER RESULTS FOR THIS PATIENT. NO KNOWN ADVERSE EFFECT TO THE PATIENT WAS REPORTED. BOTH PATIENTS HAD BEEN ADMITTED TO THE HOSPITAL PRIOR TO THE UNNECESSARY TRANSFUSION; PATIENTS' DIAGNOSIS AND/ OR CONDITIONS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700902 SYSMEX XE -5000 ANALYZER AUTOMATED HEMATOLOGY ANALZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other