BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3972118 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01801
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND THAT THE DRAIN LINE FOR THE PROBE WASH WAS CLOGGED. THE FSE BLEACHED THE WASTE AND VACUUM LINES TO FLUSH OUT THE CLOG AND THE INSTRUMENT RAN WITHOUT ANY LEAKS OR ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THE INSTRUMENT WAS GENERATING VACUUM ERRORS WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 1 ML, IDENTIFIED AS FROM THE PROBE ASSEMBLY, AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT WAS RUNNING QUALITY CONTROL SAMPLES WHEN THE LEAK WAS IDENTIFIED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THE OPERATOR WAS WEARING LAB COAT AND GLOVES WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF BIOHAZARDOUS EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447799 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1