BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3141153 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-00945
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A BENT SAMPLE PROBE. THE FSE REPLACED THE PROBE AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A BENT SAMPLE PROBE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLOODY LEAK OF APPROXIMATELY 1 ML ON THE TOP OF THE CONTROL VIALS FOLLOWING TWO TO THREE ASPIRATIONS OF THE CONTROLS INVOLVING THE COULTER AC*T DIFF 2 ANALYZER. THE CUSTOMER OBSERVED THE LEAK ON THE EXTERIOR OF THE CONTROL VIALS AND REPORTED THAT THE CONTROLS HAD GENERATED LOW RBC (RED BLOOD CELL) AND WBC (WHITE BLOOD CELL) RESULTS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF EYEWEAR AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AS NO PATIENT SAMPLES WERE AFFECTED 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
    243198 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1