BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 3854762 · Received June 6, 2014

    Report

    Report Number
    1061932-2014-01287
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE WBC APERTURE BATH ASSEMBLY TO RESOLVE THE WBC BACKGROUND FAILURES. THE FSE VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    WHILE ON SITE TO INVESTIGATE A REPORT OF A LEAK FROM THE COULTER AC*T DIFF 2 ANALYZER, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE INSTRUMENT WAS GENERATING WHITE BLOOD CELL (WBC) BACKGROUND FAILURES. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS GENERATED AND NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331591 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1