BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXH500 HEMATOLOGY INSTRUMENT

    MDR report key: 11700487 · Received April 21, 2021

    Report

    Report Number
    1061932-2021-00060
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 21, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELDS SERVICE ENGINEER (FSE) COULD NOT IDENTIFY A SPECIFIC MALFUNCTION OR FAULTY PART ASSOCIATED TO THIS EVENT. THERE WAS NO REPAIR OR REPLACEMENT OF A COMPONENT PERFORMED. THE CUSTOMER DID NOT CALL BACK WITH A RECURRENCE OF THE EVENT AS OF (B)(6)2021. SECTION A PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. BEC INTERNAL IDENTIFIER CASE: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DXH 500 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUSLY HIGH PLATELET (PLT) RESULTS ON ONE PATIENT WITH NO FLAGGING OR ALERT ON PLT CLUMPS THE PATIENT SAMPLE WAS INITIALLY RUN ON A DXH 800 HEMATOLOGY INSTRUMENT WHICH GENERATED R FLAGS AND A PLT RESULT OF 14.0 AND PROMPTED THE OPERATOR TO REVIEW THE RESULTS. THEY RERAN THE PATIENT ON THE DXH 500 GENERATING MUCH HIGHER PLT RESULTS (125.4) PROMPTING FOR A MANUAL SLIDE REVIEW THAT COINCIDED WITH THE INITIAL RUN ON THE DXH 800 AND CONFIRMED PLT CLUMPS ON THE SAMPLE. THERE WAS NO INDICATION OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY RAW DATA FROM THE INSTRUMENT WAS REQUESTED BUT NOT PROVIDED. PATIENT RESULTS WERE PROVIDED AND ASSESSED FOR THIS EVENT. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULTS OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597542 DXH500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC. TN,DXH 500 15099590671242

    Patients

    Seq Age Sex Outcome Treatment
    1