BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2120820 · Received June 11, 2011

    Report

    Report Number
    1061932-2011-00615
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATE PROBE AND THERE HAVE BEEN NO ADDITIONAL REPORTS OF BLOOD LEAKING FROM SAMPLE TUBES. ROOT CAUSE IS ATTRIBUTED TO THE ASPIRATE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT SAMPLE TUBES LEAKED BLOOD FROM WHERE THEY HAD BEEN PIERCED BY THE ACT DIFF2 INSTRUMENT. THE CUSTOMER WORE PPE AT ALL TIMES WHEN HANDLING THE TUBES AND THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO INJURY, DEATH OR CHANGE TO PATIENT TREATMENT IS RELATED TO THIS CF.

    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