BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF AUTOLOADER (AL) ANALYZER

    MDR report key: 3010025 · Received March 19, 2013

    Report

    Report Number
    1061932-2013-00377
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEC FSE RESOLVED THE NRBC AND PLT AGGREGATES FLAGS BY REPLACING THE SOLENOID SOL 35 AND THE REAGENT SYRINGE. TO RESOLVE THE BATH OVERFLOW ISSUE, THE FSE OBSERVED THAT THE RINSE BLOCK WAS PUTTING TOO MUCH FLUID INTO THE RINSE AND DIFF BATHS AND FOUND THAT THE SOLENOID SOL 11 NOT WORKING AND REPLACED THE SOLENOID BANK 1-12 AND ITS CABLE. THE FSE RESOLVED THE WBC FLAGS CONTROL ISSUE BY REPLACING THE WBC APERTURE. THE FSE CALIBRATED AND VERIFIED INSTRUMENT PERFORMANCE. PER OPERATOR'S GUIDE / IFU: WARNINGS AND PRECAUTIONS: BECKMAN COULTER INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THE COULTER ACT 5 DIFF AUTOLOADER (AL) INSTRUMENT FAILED START UP AND WHILE RUNNING CONTROLS THE CUSTOMER OBSERVED NUCLEATED RED BLOOD CELL (NRBC) AND PLATELET (PLT) AGGREGATE AND WHITE BLOOD COUNT FLAGS. THE CUSTOMER DISCONTINUED FROM USING THE INSTRUMENT UNTIL SERVICE ARRIVED. THE CUSTOMER CONFIRMED THAT NO PATIENT RESULTS WERE RUN. THEREFORE, NO ERRONEOUS PATIENT RESULTS WERE GENERATED DURING THIS EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED THAT THE RINSE AND DIFFERENTIAL BATH WERE OVERFLOWING DUE TO THE RINSE BLOCK PUTTING TOO MUCH FLUID INTO THE BATHS. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113334 COULTER AC*T 5 DIFF AUTOLOADER (AL) ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1