BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 3885232 · Received June 19, 2014

    Report

    Report Number
    1061932-2014-01397
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED SOLENOID LV13 AND FOUND A CLOT IN VACUUM PORT ON PROBE WIPE. HE REMOVED THE CLOT AND VERIFIED INSTRUMENT PERFORMANCE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF ANALYZER. THE LEAK WAS A DILUENT LEAK OF APPROXIMATELY 1ML FROM THE ANALYZER AND WAS NOT CONTAINED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT INCLUDING GLOVES AND LAB COAT. THERE WERE NO REPORTS OF BIOHAZARDOUS EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361517 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1