BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF ANALYZER

    MDR report key: 3882430 · Received June 18, 2014

    Report

    Report Number
    1061932-2014-01390
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 A WHITE BLOOD CELL (WBC) APERTURE ALERTS AND THE PROBE LEAKED DURING STARTUP. THE FSE ALSO OBSERVED THE PINCH VALVE LV8 WAS NOT ACTUATING. THE FSE REPLACED THE PINCH VALVE LV8 TO RESOLVE THE LEAK ISSUE. THE FSE ALSO ADJUSTED THE APERTURE VOLTAGE RATIO (AVR) TO RESOLVE THE WBC APERTURE ALERTS. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING WHITE BLOOD CELL (WBC) APERTURE AND A DROP OF DILUENT LEAKED FROM THE PROBE OF THE COULTER AC·T DIFF ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. 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
    357200 COULTER AC·T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1