BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC*T DIFF 2

    MDR report key: 2342843 · Received November 18, 2011

    Report

    Report Number
    1061932-2011-02238
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE CONTROL DIFFERENTIAL RESULTS ON THE ACT DIFF 2 INSTRUMENT WERE FLAGGING. AFTER REPLACING SOME TUBING, THE CUSTOMER NOTICED THE PROBE WIPE BEGAN TO DRIP DILUENT AND SERVICE WAS RECOMMENDED. THE OPERATOR WAS WEARING GLOVES AND A GOWN DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. THE CUSTOMER DOES HAVE AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AND HAS NOT REVIEWED MSDS. PER CONVERSATION WITH THE SUBMITTER, PATIENT RESULTS WERE NOT AFFECTED, THE ABNORMAL WBC HISTOGRAM WAS ONLY OBSERVED ON CONTROLS. THE FIELD SERVICE ENGINEER (FSE) REPLACED PINCH TUBING, THE PROBE, PROBE WIPE, AND HGB LAMP. HE INDICATED THE "DIFFERENTIAL" PROBLEM APPEARS TO BE RELATED TO THE STRECK CONTROLS ONLY. AN ORACLE SEARCH ON (B)(6) 2011 DOES NOT SHOW ANY REOCCURRENCE OF THE LEAK. BASED ON INFORMATION PROVIDED, THE ROOT CAUSE FOR THE PROBE WIPE DRIP CANNOT BE DETERMINED; HOWEVER, THE PROBE AND PROBE WIPE ASSEMBLY WERE REPLACED. 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 IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1