BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2¿ ANALYZER

    MDR report key: 3022232 · Received March 26, 2013

    Report

    Report Number
    1061932-2013-00503
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING VIA THE TELEPHONE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY FEW DROPS OF DILUENT LEAKED OUTSIDE THE INSTRUMENT AT THE PROBE AND ON TOP OF SAMPLE TUBES INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER WAS ADVISED TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING AND WAS WEARING PROTECTIVE GLOVES AND A LABORATORY COAT. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT GUIDED THE CUSTOMER TO REMOVE THE PROBE WIPE BLOCK AND CLEAN IT WITH BLEACH AND WATER. THE CUSTOMER REATTACHED THE PROBE WIPE BLOCK AFTER CLEANING AND RESOLVED THE ISSUE. NO FURTHER FLUID LEAKS WERE NOTED. THE CUSTOMER INDICATED SYSTEM STARTUP AND CONTROLS WERE WITHIN THE ACCEPTABLE RANGE AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123776 COULTER® ACT DIFF 2¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1