BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 520 HEMATOLOGY INSTRUMENT

    MDR report key: 10541718 · Received September 16, 2020

    Report

    Report Number
    1061932-2020-00145
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    GKZ
    UDI-DI
    15099590679781
    PMA / PMN Number
    K181475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DXH520 OPERATOR DID NOT SCAN THE SPECIMEN TUBES BAR CODE, AND DID NOT VERIFY THE NEXT SPECIMEN ID WAS CORRECT BEFORE RUNNING THE SAMPLE. THE CUSTOMER WAS PROVIDED RETRAINING ON RUNNING SAMPLES IN PRIMARY MODE. PER DXH520 V2 IFU, PN B85528AA: CREATING A WORKLIST: PATIENT INFORMATION AND SPECIMEN IDS CAN BE ADDED TO A WORKLIST. THE INFORMATION IS EITHER DOWNLOADED FROM THE HOST LIS SYSTEM OR YOU CAN MANUALLY ENTER THE INFORMATION INTO THE WORKLIST. NOTE: A VALID SPECIMEN ID MUST BE ENTERED TO ANALYZE A SPECIMEN. IF YOU HAVE SET UP AUTOINCREMENTING, THE SPECIMEN ID FIELD WILL BE AUTOMATICALLY POPULATED. IF NO SPECIMEN ID EXISTS, THE SYSTEM ASSIGNS AN AUTOSID. PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. BEC INTERNAL IDENTIFIER: (B)(4).

    Description of Event or Problem · 1

    THE BECKMAN COULTER APPLICATIONS REPRESENTATIVE REPORTED THE CUSTOMER WAS NOT SCANNING THE BARCODE ON SPECIMEN TUBES PROCESSED ON THEIR DXH520 INSTRUMENT WHEN RUNNING SAMPLES IN PRIMARY (CLOSED VIAL) MODE. THE CUSTOMER WAS NOT CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT OR MATCHING THE SAMPLE BEING PROCESSED, RESULTING IN PATIENT RESULT MISIDENTIFICATION. THE REPORTED FAILURE MODE OCCURRED WHEN THE OPERATOR DID NOT SCAN THE SAMPLE BAR CODE, NOR CONFIRMED THE NEXT SPECIMEN ID WAS CORRECT. THE OPERATOR ACKNOWLEDGED THE ¿OK¿ ICON ON POPUP WINDOW CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT, THEN INSERTS THE MIXED SAMPLE INTO THE TUBE HOLDER AND PRESSES THE RUN ICON. SELECTING THE RUN ICON WILL CLOSE TUBE HOLDER DOOR AND INITIATE AN ANALYTICAL CYCLE. ON SUBSEQUENT SAMPLE RUNS, THE POPUP WINDOW: ¿VERIFY NEXT SPECIMEN ID IS NOT DISPLAYED¿." HOWEVER, AS SPECIMENS ARE PROCESSED, IF ANY ENTRY EXIST ON THE WORKLIST, THE NEXT SPECIMEN ID FIELD ON THE SAMPLE ANALYSIS. PATIENT RESULTS SCREEN AUTOMATICALLY DISPLAYS THE FIRST SPECIMEN ID FROM THE WORKLIST AS THE NEXT SPECIMEN TO BE PROCESSED. THE SPECIMEN ID IS USED TO MATCH THE RESULTS TO AN ENTRY ON THE WORKLIST. THERE WAS NO DEATH, OR INJURY ASSOCIATED WITH THIS INCIDENT, IT WAS CONFIRMED THAT NO ERRONEOUS OR MISLABELED RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT IN THIS EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008306 UNICEL DXH 520 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC TN,DXH 520 CP HEMATOLOGY INSTRUMENT 15099590679781

    Patients

    Seq Age Sex Outcome Treatment
    1