BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3894416 · Received June 25, 2014

    Report

    Report Number
    1061932-2014-01480
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, BECKMAN COULTER CUSTOMER SUPPORT WORKED WITH THE CUSTOMER TO DRAIN THEN FILL THE BATHS SEVERAL TIMES, AFTER WHICH THERE WAS THE BATHS DID NOT OVERFLOW, AND THE LEAK WAS RESOLVED. ON 06/04/2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND THAT THE LEAK HAD BEEN RESOLVED BY CUSTOMER PRIOR TO HIS ARRIVAL TO SITE. THE LEAK WAS ATTRIBUTED TO BATHS OVERFLOWING AND NOT TO DRAINING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THE LEAK WAS DESCRIBED AS APPROXIMATELY 1 CUP OF CLEAR FLUID LEAKED FROM THE INSTRUMENT ONTO THE COUNTER. THE INSTRUMENT WAS RUNNING A STARTUP PROCEDURE WHEN THE LEAK WAS IDENTIFIED. THE CUSTOMER OPENED THE FRONT COVER AND FOUND THAT THE WBC (WHITE BLOOD CELL) AND RBC (RED BLOOD CELL) BATHS WERE OVERFLOWING. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371381 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1