BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3200719 · Received July 1, 2013

    Report

    Report Number
    1061932-2013-01268
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE PROBE WIPE TO RESOLVE THE ISSUES. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE PROBE WIPE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEARING NOISE FROM THE PROBE WHEN RUNNING QC (QUALITY CONTROL) INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER ALSO INDICATED THAT THE CP (CAP PIERCE) DOOR WOULD NOT OPEN. THE CUSTOMER DISCOVERED A LEAK FROM THE PROBE ABOVE THE CP MECHANISM DOOR AND THAT THE DOOR WAS WET WITH FLUID. THE CUSTOMER STATED THAT LESS THAN 5 ML OF FLUID LEAKED AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297857 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1