BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF 2 ANALYZER

    MDR report key: 4003881 · Received August 12, 2014

    Report

    Report Number
    1061932-2014-01888
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED THE SWEEP FLOW LINE TUBING HAD BECOME DISCONNECTED FROM THE BACK OF THE RED BLOOD CELL (RBC) BATH. THE FSE REATTACHED THE TUBING AND THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS OR ERRORS. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING 'VACUUM' ERRORS AND APPROXIMATELY 1 ML OF CLEAR FLUID LEAKED FROM THE COULTER AC·T DIFF 2 ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING GLOVES 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
    479957 COULTER AC·T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1