BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 4409279 · Received January 12, 2015

    Report

    Report Number
    1061932-2015-00065
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/16/2015, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND A LEAK THAT WAS CAUSED BY A MIXING BUBBLE CHECK VALVE (PN 6214108) THAT BECAME DISCONNECTED FROM THE TUBING BETWEEN IT AND THE WHITE BLOOD CELL (WBC) BATH. THE FSE TRIMMED THE END OF THE TUBING AND RECONNECTED THE CHECK VALVE WHICH RESOLVED THE LEAK AND ERRORS. THE INSTRUMENT RAN WITHOUT LEAKS OR ERRORS AND ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSTRUMENT STARTUP PROCESS FAILED FOR ALL PARAMETERS WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER PERFORMED ROUTINE TROUBLESHOOTING WITHOUT RESOLUTION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE CONFIRMED THE INSTRUMENT STARTUP PROCESS FAILED FOR ALL PARAMETERS, AND INCOMPLETE COMPUTATIONS FOR RED BLOOD CELL (RBC), HEMOGLOBIN AND PLATELET TESTS, AND VOTEOUTS FOR WHITE BLOOD CELL (WBC) TESTS. WHILE INVESTIGATING THE CAUSE OF THESE ISSUES, THE FSE IDENTIFIED A LEAK IN THE ANALYZER. THE LEAK WAS CAUSED BY THE FIRST MIX CHECK VALVE BECOMING DISCONNECTED FROM THE TUBING BETWEEN IT AND THE WBC BATH. THE LEAK CONSISTED OF PATIENT SAMPLE, DILUENT, AND LYTIC REAGENT (<10ML). THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. OPERATORS WERE NOT EXPOSED TO THE LEAK AND DID NOT IDENTIFY THE LEAK. THE OPERATORS DID NOT OPEN ANY DOORS OR COVERS THAT WOULD HAVE EXPOSED THEM TO THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WERE NO REPORTS OF EXPOSURE OF MUCOUS MEMBRANES OR CUTS TO BIOHAZARDOUS MATERIAL. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT. THE LEAK WAS CLEANED AND DECONTAMINATED BY THE FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26059 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1