BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER DXH DILUENT

    MDR report key: 4050730 · Received September 2, 2014

    Report

    Report Number
    1061932-2014-02179
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GIF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2050012-08/25/2014-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED COULTER DXH DILUENT LOT NUMBER 3510530 ONBOARD THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, SERIAL NUMBER (B)(4) WITH ANOTHER COULTER DXH DILUENT LOT NUMBER, RAN THE REMOVE CLEANER PROCEDURE, PRIMED DILUENT AND PERFORMED DAILY CHECKS AND THE ISSUE WAS RESOLVED. (B)(4). THIS MDR IS RELATED TO ANOTHER MDR 1061932-2014-02178 FOR THE SAME ISSUE ON THE SECOND UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PLATELET BACKGROUND HIGH FAILURES ON TWO UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS IN THE CUSTOMER'S LABORATORY WHEN USING A SPECIFIC LOT NUMBER OF COULTER DXH DILUENT. THERE WERE NO ERRONEOUS TEST RESULTS WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533847 COULTER DXH DILUENT BLOOD CELL DILUENT GIF BECKMAN COULTER NA 3510530

    Patients

    Seq Age Sex Outcome Treatment
    1