BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF CP ANALYZER

    MDR report key: 1994174 · Received February 16, 2011

    Report

    Report Number
    1061932-2011-00080
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND NO ERRORS OR MALFUNCTIONS ON THE INSTRUMENT. PER THE FSE, THE INSTRUMENT OPERATION WAS NORMAL AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE SMOKE SMELL IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A BURNING SMELL FROM THE COULTER AC*T 5 DIFF CP ANALYZER WHILE TROUBLESHOOTING (TS) A FLAGGING ISSUE ON THE INSTRUMENT. SERVICE HAD PERFORMED ON THIS UNIT PRIOR TO THIS EVENT. THE CUSTOMER WAS INSTRUCTED TO WEAR PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) DURING THE TS STEPS. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER. NO ONE SOUGHT MEDICAL ATTENTION. NO IMPACT TO PATIENT RESULTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF CP ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T 5 DIFF CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1