BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER DXH DILUENT

    MDR report key: 4050735 · Received September 2, 2014

    Report

    Report Number
    1061932-2014-02180
    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

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER REPLACED THE COULTER DXH DILUENT LOT NUMBER 3510530 WITH COULTER DXH DILUENT LOT NUMBER 3510680. HE RAN REMOVE CLEANER, PRIME SWEEP FLOW AND PRIME DILUENT FUNCTIONS. DAILY CHECK WAS PERFORMED; ALL PARAMETERS PASSED, ALONG WITH QC. (B)(4). THIS MDR IS RELATED TO MDR 1061932-2014-02182 FOR ANOTHER OCCURRENCE FOR THE SAME CUSTOMER FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PLATELET BACKGROUND HIGH FAILURES ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM 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
    532889 COULTER DXH DILUENT BLOOD CELL DILUENT GIF BECKMAN COULTER NA 3510530

    Patients

    Seq Age Sex Outcome Treatment
    1