BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2562354 · Received May 7, 2012

    Report

    Report Number
    1061932-2012-01513
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THEY NOTICED A SMALL CLEAR RESIDUE ON TOP OF ONE OF THE VIALS. CUSTOMER REPORTED THAT UPON INSPECTION, THEY FOUND CLEAR FLUID ON TOP OF THE PROBE WIPE BLOCK OF THE COULTER ACT DIFF 2 ANALYZER. CUSTOMER REPORTED THAT THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. CUSTOMER REPORTED THAT THEY FOLLOWED INSTRUCTIONS ON THE OPERATOR'S MANUAL TO CLEAN THE PROBE WIPE BLOCK. CUSTOMER REPORTED THAT QUALITY CONTROL HAD RECOVERED WITHIN SPECIFICATIONS. BEC CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER ON CLEANING THE PATHWAY FROM THE PROBE WIPE BLOCK TO VALVE LV8. CTS INSTRUCTED THE CUSTOMER TO REPLACE THE AIR FILTER. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND WORN DRAIN TUBING AT VALVE LV8 CAUSING A LESS EFFECTIVE PROBE WIPE WHICH RESULTED IN FLUID BEING LEFT ON TOP OF THE TUBE. THE FSE REPLACED THE DRAIN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1