BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T DIFF ANALYZER

    MDR report key: 3903606 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01494
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 LEAK FROM THE PROBE WIPE. THE FSE CLEARED A CLOG FROM VACUUM PORT 5 OF THE PROBE WIPE TO RESOLVE THE LEAK ISSUE. THE FSE ALSO NOTED THAT THE HEMOGLOBIN (HGB) VOLTAGE WAS FAILING AND REPLACED THE HGB LAMP. THE FSE PERFORMED INSTRUMENT VERIFICATION AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 1 TO 2 ML OF FLUID LEAKED FROM PROBE OF THE AC·T DIFF ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS 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
    379559 COULTER AC·T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1