BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT SERIES ANALYZER

    MDR report key: 2942753 · Received February 4, 2013

    Report

    Report Number
    1061932-2013-00172
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 SEVERAL MILLILITERS OF FLUID LEAKED FROM THE PROBE AND OUTSIDE THE INSTRUMENT, AFTER SAMPLE ANALYSIS INVOLVING THE COULTER ACT SERIES ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT. THE CUSTOMER BLEACHED THE PROBE WIPE PATHWAY, PERFORMED SYSTEM STARTUP, AND COMPLETED A SAMPLE ANALYSIS. NO FURTHER EVIDENCE OF FLUID LEAK WAS NOTED. THE INSTRUMENT WAS IN NORMAL OPERATION. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46624 COULTER® ACT SERIES ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1