BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2192406 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01119
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PERFORM TROUBLESHOOTING WITH A BEC FIELD SERVICE ENGINEER (FSE). THE CUSTOMER REQUESTED FOR A WASTE OUTPUT TUBING REPLACEMENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE WASTE OUTPUT TUBING OF THE COULTER AC T DIFF 2 HEMATOLOGY ANALYZER WAS LEAKING. AN INSTRUMENT SUBJECT MATTER EXPERT (SME) INDICATED THAT THERE IS ONLY ONE WASTE PATHWAY AND THE CONTENTS THAT PASS THROUGH IT ARE BLOOD, LYSE, CLENZ AND DILUENT. THE OPERATORS WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GOWN, GLOVES AND GLASSES AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1