BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 520 HEMATOLOGY INSTRUMENT

    MDR report key: 11636161 · Received April 8, 2021

    Report

    Report Number
    1061932-2021-00057
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    GKZ
    UDI-DI
    15099590679781
    PMA / PMN Number
    K181475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND CONFIRMED WHAT THE CUSTOMER REPORTED. THE FSE SUSPECTED THAT THE VACUUM LINE FROM THE SYRINGE WAS PINCHED. TO RESOLVE THE ISSUE THE FSE FLUSHED THE VACUUM LINE AND WBC FILTER. BEC INTERNAL IDENTIFIER - CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING ERRONEOUS PLATELET (PLT) RESULTS ON A PATIENT SAMPLE AND INTERMITTENT SYRINGE VACUUM ERRORS ON THEIR DXH 520 HEMATOLOGY INSTRUMENT. CUSTOMER STATED THEY HAVE GOTTEN THE SYRINGE VACUUM ERROR SEVERAL TIMES IN THE PAST MONTH. CUSTOMER REPORTED THAT THEY HAD ONE SAMPLE THAT WAS NOT GIVING THE CORRECT RESULTS ON PLT. THE CUSTOMER SAID THE SAMPLE GAVE A RESULT OF 483 AND WHEN RERUN RESULTED IN 2353. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS CONSISTENT FOR THE PATIENT AND CONSIDERED CORRECT. THE RESULTS FROM THE DXH 520 WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THE DXH 520 HAD GENERATED ABNORMAL DIFF, CELLULAR INTERFERENCE, AND LARGE CELL MESSAGES. IT COULD NOT BE CONFIRMED IF BOTH OF THE RUNS GENERATED MESSAGES. PATIENT DATA WAS REQUESTED BUT HAS NOT BEEN PROVIDED. THE CUSTOMER LAB SAID THAT THE INITIAL COMPLAINANT HAS THE INFORMATION AND WILL BE OUT OF THE OFFICE FOR SEVERAL WEEKS. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534020 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