BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF 2 ANALYZER

    MDR report key: 3972122 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01776
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED THE CUSTOMER OVER THE PHONE TO OPEN THE RIGHT SIDE DOOR OF THE INSTRUMENT. THE CUSTOMER OBSERVED THE DUAL RED BLOOD CELL COUNT (RBC) FILTERS WERE WET AND THE FOAM TRAP WAS MOIST INSIDE THE INSTRUMENT. THE CUSTOMER TIGHTENED ALL FILTER CONNECTIONS THAT WERE LOOSE AND PERFORMED STARTUP AND THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 MLS OF CLEAR FLUID LEAKED FROM THE RIGHT SIDE OF THE COULTER AC·T DIFF 2 ANALYZER. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING GLOVES, GLASSES, AND A LAB COAT AT THE TIME OF THE INCIDENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448221 COULTER AC·T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1