BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 3399774 · Received October 10, 2013

    Report

    Report Number
    1061932-2013-02214
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 12, 2013
    Report Date
    September 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE STARTUP FAILURES BEGAN AFTER CHANGING REAGENTS. THE BATH ASSEMBLIES WERE CLEANED WHICH DID NOT RESOLVE THE ISSUE. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN DETERMINING THE CAUSE OF THE ISSUES. THE CUSTOMER WAS INSTRUCTED TO OPEN THE INSTRUMENT AND DISCOVERED A LEAK AND THAT THE WBC BATH WAS OVERFLOWING. THE CUSTOMER ENSURED THE WASTE CONTAINER WAS NOT FULL ALONG WITH PERFORMING A RINSING AND MIXING CYCLE ON THE BATHS. THE BATHS WERE NOW DRAINING CORRECTLY. THE SYSTEM STARTUP AND CONTROL TESTS WERE SUCCESSFUL AND THERE WAS NO FURTHER LEAKS OBSERVED BY THE CUSTOMER. A DEFINITIVE FAILURE MODE COULD NOT BE DETERMINED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER CORRECTED THE ISSUE. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT 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) REPORTING A FLUID LEAK OF APPROXIMATELY 1 ML COMING FROM THE RIGHT HAND SIDE OF THE COULTER AC T DIFF 2 ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. PRIOR TO THE DISCOVERY OF THE LEAK THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED WHITE BLOOD COUNT (WBC), HEMOGLOBIN (HGB), AND PLATELET (PLT) BACKGROUND FAILURES UPON STARTUP. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519559 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1