BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2020791 · Received March 16, 2011

    Report

    Report Number
    1061932-2011-00134
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE RM CAR READER. HE RAN QC AND STARTUP AND THE RESULTS WERE WITHIN SPECIFICATIONS. ROOT CAUSE WAS REAGENT MANAGEMENT CARD READER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBSERVING SMOKE EMITTING FROM THE COULTER DIFF ACT2 ANALYZER. THE CUSTOMER REPORTED SHE PLACED A USED REAGENT MANAGEMENT (RM) CARD INTO THE RM CARD READER TO DOWNLOAD IQAP DATA. THE CUSTOMER ATTEMPTED TO REMOVE THE RM CARD WHEN THE ENTIRE RM CARD READER CAME OUT. THE CUSTOMER PUSHED THE RM CARD READER BACK INTO THE INSTRUMENT, WHEN SHE NOTICED THE SMOKE. CUSTOMER IMMEDIATELY POWERED INSTRUMENT OFF AND CONTACTED BCI TECHNICAL SUPPORT, WHO INSTRUCTED CUSTOMER TO UNPLUG INSTRUMENT. NO INJURY OR EXPOSURE/CONTACT TO EYE, SKIN, OPEN WOUNDS, OR MUCUS MEMBRANE HAD OCCURRED. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1