BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 520 HEMATOLOGY INSTRUMENT

    MDR report key: 10615037 · Received October 1, 2020

    Report

    Report Number
    1061932-2020-00158
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 1, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE DXH520 INSTRUMENT. HE ANEW LOT OF CONTROLS FOR THE CUSTOMER AND ALSO SUSPECTED THAT A RECENTLY REPLACED MAIN BOARD COULD HAVE CONTRIBUTED TO THE ISSUE. THE FSE ALSO ADJUSTED THE MEAN CHANNEL OF THE RBC LATEX AND REPLACED THE MAIN CARD. HE THE RAN DAILY CHECKS, REPEATABILITY, CARRYOVER, LATEX AND QC SUCCESSFULLY. PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. BEC INTERNAL IDENTIFIER CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING ERRONEOUS HIGH PLATELET (PLT) RESULTS ON THREE (3) PATIENTS AND QC WHILE USING THEIR DXH 520 HEMATOLOGY INSTRUMENT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE CUSTOMER RAN THE QC VIALS ON THE MORNING OF THE OCCURRENCE AND THEY PASSED, EVEN THOUGHT THEY WERE EXPIRED. THE CUSTOMER BEGAN RUNNING SAMPLES AND 3 OF THE PATIENT SAMPLES HAD HIGH PLT RESULTS, THE CUSTOMER MIXED THE SAMPLES AND RE-RAN THEM. THE SECOND PLT RESULT WAS HIGHER THAN THE FIRST RUN. THE CUSTOMER DID NOT REPORT THE RESULTS OUT AND SENT THE SAMPLES OUT TO GET TESTED ELSEWHERE. THE RESULTS OF THE LAST RUN WERE REQUESTED BUT THE CUSTOMER SAID THEY DID NOT HAVE THOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082017 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