BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXH500 HEMATOLOGY INSTRUMENT

    MDR report key: 11737832 · Received April 28, 2021

    Report

    Report Number
    1061932-2021-00062
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    GKZ
    UDI-DI
    15099590671242
    PMA / PMN Number
    K181475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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) INSPECTED THE INSTRUMENT AND CONFIRMED THE REPORTED ISSUE FROM THE CUSTOMER. THE ASSIGNABLE CAUSE OF THE REPORTED EVENT WAS A FAULTY O-RING AT THE PROBE. WHILE REPLACING THE O-RING THE FSE OBSERVED THAT THERE WAS DRIED BLOOD ON THE TOP OF THE ASSEMBLY AND PERFORMED THE CLEANING FUNCTION TO THE ASSEMBLY AS WELL. THE INSTRUMENT WAS THEN VERIFIED TO MEET THE PUBLISHED PERFORMANCE SPECIFICATIONS. BEC INTERNAL IDENTIFIER - CASE-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGHER PLATELET (PLT) VALUES THAN EXPECTED ON PATIENT SAMPLES THAT WERE RUN ON THEIR DXH 500 HEMATOLOGY INSTRUMENT. THE SAMPLES IN QUESTION WERE SENT TO REFERENCE LAB AND CONFIRMED TO BE ERRONEOUSLY HIGHER ON THE DXH 500. THERE WAS NO REPORT OF CHANGE OR EFFECT ON PATIENT TREATMENT. THE CUSTOMER INDICATED THAT CONTROLS WERE FAILING TO RECOVER WITHIN THE EXPECTED RANGES (HIGH PLT), AND ATTEMPTED SEVERAL TIMES IN ORDER FOR THE CONTROLS TO PASS. ONCE THE CONTROLS PASSED, THE CUSTOMER BEGAN USING THE INSTRUMENT TO PROCESS PATIENT SAMPLES. THE CUSTOMER REPORTED THAT THERE WERE A NUMBER PATIENT SAMPLES THAT HAD HIGHER RESULTS FOR PLATELETS THAN EXPECTED. THE CUSTOMER SENT THESE SAMPLES TO THE REFERENCE LAB AND CONFIRMED THE PLT VALUES WERE HIGHER ON THE DXH500 AND THE LOWER VALUES WERE CONSIDERED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638148 DXH500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC. TN,DXH 500 15099590671242

    Patients

    Seq Age Sex Outcome Treatment
    1