BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF ANALYZER

    MDR report key: 3850166 · Received June 5, 2014

    Report

    Report Number
    1061932-2014-01210
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THE VALVE LV10 WAS NOT FUNCTIONING PROPERLY AFTER TROUBLESHOOTING, CAUSING THE DILUENT PUMP TO NOT SHUTOFF WHICH CAUSED THE DILUENT TO CONTINUE TO THE TOP OR THE PROBE-WIPE HOUSING AND LEAK. THE FSE REPLACED THE VALVE LV10 TO RESOLVE THE ISSUES. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PROBE OF THE COULTER AC·T DIFF ANALYZER LEAKED ABOUT 4 OZ OF FLUID ONTO THE COUNTER DURING STARTUP. THE CUSTOMER WAS WEARING GLOVES, GOGGLES, AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329629 COULTER AC·T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1