BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3160232 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01081
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED RBC'S HIGH ON BACKGROUND COUNT. THE FSE REPLACED THE SWEEP FLOW CHECK VALVE AND TIGHTENED THE SWEEP FLOW CONNECTOR, AND THE RED BLOOD COUNT (RBC) BACKGROUND PASSED. THE FAILURE MODE WAS RELATED TO THE SWEEP FLOW CHECK VALVE WHICH NEEDED REPLACEMENT AND THE SWEEP FLOW CONNECTOR WHICH WAS RETIGHTENED. THE INSTRUMENT PERFORMED AS EXPECTED, FAILING THE RBC START UP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THEIR CONCERNS IN REGARD TO THE COULTER AC *T DIFF 2 ANALYZER WHICH WAS JUST INSTALLED AT THE CUSTOMER'S SITE. THE CUSTOMER INDICATED THAT THE ANALYZER HAD MULTIPLE SERVICE CALLS DURING THE VALIDATION PERIOD. PER INFORMATION RECEIVED FROM THE CUSTOMER, THE INSTRUMENT REMAINED IN VALIDATION STATUS FROM THE TIME OF INSTALLATION UNTIL (B)(6) 2013. ONLY QUALITY CONTROL (QC) AND COMPARISON STUDIES WERE RUN ON THE ACT DIFF 2 ANALYZER DURING THIS TIME. POST (B)(6) 2013, THE INSTRUMENT WAS VALIDATED TO RUN PATIENT SAMPLES; HOWEVER, A PROBLEM WAS IDENTIFIED ON THE MORNING OF (B)(6) 2013 WHEN THE RED BLOOD COUNT (RBC) BACKGROUND FAILED DURING A STARTUP. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THE CUSTOMER STOPPED USING THE INSTRUMENT WHEN THE STARTUP FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260831 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1