BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 5429246 · Received February 10, 2016

    Report

    Report Number
    1061932-2016-00157
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 19, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DEVICE DATE OF MANUFACTURE WAS CHANGED FROM 08/01/2004 02/01/2005.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 01/22/2016. AFTER TROUBLESHOOTING ANOTHER ISSUE THE FSE FOUND THAT CONTROLS FOR WBC WERE FAILING. THE FSE FOUND THAT THE WBC BATH WAS FAULTY. THE FSE REPLACED THE WBC BATH, WHICH REPAIRED THE FAILING WBC RESULTS ON CONTROLS. THE REPAIRS WERE VERIFIED BY THE FSE. THE BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(6).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED THE COULTER ACT DIFF 2 ANALYZER WAS RECOVERING ERRONEOUS WHITE BLOOD CELL (WBC) RESULTS ON CONTROLS. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86293 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1