BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3202957 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01246
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED THAT THE RINSE BLOCK WAS LEAKING ON A STARTUP AFTER SHUTDOWN ONLY. THE FSE REPLACED DUAL DILUENT FILTERS, BLUE DILUENT FILTERS, VACUUM ISOLATOR CHAMBER (VIC), CHECK VALVE, AND VALVE VL10 TO ADDRESS THE ISSUE. FAILURE MODE WAS ATTRIBUTED TO DUAL FILTERS, BLUE DILUENT FILTERS, VIC, CHECK VALVE, AND VALVE VL10. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THE PROBE WIPE WAS LEAKING (3 DROPS) AT THE END OF THE STARTUP CYCLE ON THE COULTER ACT-DIFF ANALYZER. THE SPILL WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING GLOVES AND GOWN AT THE TIME OF THIS INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301915 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1