BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2379205 · Received December 16, 2011

    Report

    Report Number
    1061932-2011-02639
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THE PROBE ON THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER) WAS LEAKING. CUSTOMER REPORTED THAT THE HMX AUTOLOADER GENERATED "BACKWASH NOT PERFORMED" ERRORS. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE PROBE WAS BENT, PREVENTING THE RINSE BLOCK FROM MOVING AS REQUIRED TO PERFORM BACKWASH OPERATION. THE FSE STRAIGHTENED THE PROBE AND ENSURED THAT THE RINSE BLOCK COULD MOVE FREELY AND THE BACKWASH OPERATION CYCLED SUCCESSFULLY. THERE WAS NO FURTHER EVIDENCE OF LEAKING OR ERROR MESSAGES AFTER THE REPAIR. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1