BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3222771 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01354
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT BATHS WERE NOT PROPERLY DRAINING AND REPLACED THE WASTE PUMP TO RESOLVE THIS ISSUE. THE FSE ALSO REPLACED THE VACUUM AIR FILTER (FLUID BARRIER FILTER). FAILURE MODE WAS ATTRIBUTED TO THE WASTE PUMP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEIR COULTER AC *T DIFF 2 ANALYZER WAS LEAKING APPROXIMATELY 5¿10 ML OF SAMPLE/DILUENT THAT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER CONFIRMED THEY WERE WEARING GLOVES AT THE TIME OF THE EVENT. PER CUSTOMER, THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES. THE CUSTOMER STATED THAT BEFORE THE LEAK WAS DISCOVERED, THEY WERE RUNNING SAMPLES; HOWEVER, PATIENT RESULTS/TREATMENT WERE NOT AFFECTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322124 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1