BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF CAP PIERCER

    MDR report key: 2412759 · Received January 12, 2012

    Report

    Report Number
    1061932-2012-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: RINSE BLOCK. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS AN EXCESS AMOUNT OF DRIED AND MOIST REAGENT ON THE PLASTIC COVER OVER THE BATH AREA OF THE COULTER AC*T 5 DIFF CAP PIERCER. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE PROBE RINSE BLOCK WAS LEAKING. THE FSE REPLACED THE RINSE BLOCK ASSEMBLY AND O RINGS. THE FSE VERIFIED OPERATION. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF CAP PIERCER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1