BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 3982210 · Received August 5, 2014

    Report

    Report Number
    1061932-2014-01847
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED DILUENT FILTERS AND CHECK VALVE CV1 TO RESOLVE THE LEAK AND BACKGROUND FAILURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF ANALYZER. THERE WAS A FLUID LEAK OF APPROXIMATELY 2ML FROM THE ANALYZER. THE LEAK WAS NOT CONTAINED. THERE WERE BACKGROUND FAILURES DURING THE INSTRUMENT STARTUP PROCEDURE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD 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 USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457212 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1