BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2991883 · Received March 6, 2013

    Report

    Report Number
    1061932-2013-00368
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE WASTE PUMP, WHICH HAD STOPPED WORKING. THE REPAIRS, PERFORMED BY SERVICE, REPLACED THE LEAK. PER PRODUCT LABELING: BECKMAN COULTER INC RECOMMENDS AVOIDING THE USE OF ONE TYPE OF MESSAGE OR OUTPUT TO SUMMARIZE RESULTS OR PATIENT CONDITIONS. BECKMAN COULTER INC DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. PER LABELING, 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK OF CLEAR FLUID THAT APPEARED AFTER RUNNING A PATIENT SAMPLE ON THE COULTER ACT DIFF 2 HEMATOLOGY ANALYZER. THE VOLUME WAS REPORTED AS APPROXIMATELY A 1/3 CUP AND WAS NOT CONTAINED. THE LEAK DID NOT AFFECT SAMPLE OR REAGENT INTEGRITY. IT DID NOT IMPACT ELECTRICAL OR OPTICAL PERFORMANCE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES ONLY DURING THIS EVENT. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE GENERATED OR REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT THERE HAS BEEN NO AFFECT TO PATIENT TREATMENT. THE PATIENT SAMPLE THAT WAS RUNNING AT THE TIME THE LEAK WAS NOTICED AND WAS SENT TO THEIR REFERENCE LABORATORY FOR ANALYSIS. INFORMATION REGARDING THE RESULTS OF THE PATIENT SAMPLE FROM THE REFERENCE LABORATORY HAS BEEN REQUESTED FROM THE CUSTOMER, BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96343 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1