BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 3781325 · Received April 30, 2014

    Report

    Report Number
    1061932-2014-00963
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER WAS NOT DISPATCHED BECAUSE CUSTOMER TECHNICAL SUPPORT (CTS) WAS ABLE TO TROUBLESHOOT THE LEAK WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER DRAINED THE WBC (WHITE BLOOD CELL) BATH AND RAN THE INSTRUMENT. THE INSTRUMENT WAS GIVING VACUUM ERRORS AND THE WBC BATH CONTINUED TO OVERFLOW. CTS INSTRUCTED THE CUSTOMER TO REPLACE THE VACUUM FILTER. THE CUSTOMER REPLACED THE VACUUM FILTER AND THE INSTRUMENT RAN WITHOUT ANY LEAKS OR ERRORS. THE CUSTOMER RAN THE INSTRUMENT TO VERIFY THAT IT WAS RUNNING 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 LEAK WAS AT THE WHITE BLOOD CELL (WBC) BATH OF THE INSTRUMENT. THE VOLUME OF THE LEAK WAS ABOUT 2 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES AND LAB COAT WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259033 COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1