BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 5230181 · Received November 17, 2015

    Report

    Report Number
    1061932-2015-01726
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS DISCOVERED INTERNALLY BY SYSTEM SOFTWARE VERIFICATION (SSV) DURING SOFTWARE REVISION 3.1 RELATED TESTING. ONLY DXH SOFTWARE REVISIONS 3.0.2.0 AND 1.1.1.0 ARE IMPACTED BY THIS ISSUE. THIS ISSUE CANNOT BE REPRODUCED WITH DXH CONNECTIVITY WITH AN SMS (I.E., DXH 801, 1601 OR 2401). THIS ISSUE CANNOT BE REPRODUCED WITH TEST ORDERS WITH RELATED RESULTS. THIS ISSUE HAS THE POTENTIAL TO RESULT IN A SAMPLE MISIDENTIFICATION LEADING TO ERRONEOUS RESULTS TO BE RELEASED OUT OF LABORATORY OR DELAY IN RELEASE OF PATIENT RESULTS TO THE PHYSICIAN. NO COMPLAINTS HAVE BEEN REPORTED FROM THE FIELD. THE ISSUE OCCURS ONLY WHEN MANUALLY EDITING A PENDING TEST ORDER. A CORRECTIVE ACTION IS IN PROCESS FOR RESOLUTION OF THE DISCOVERED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    WHILE DOING SOFTWARE VALIDATION TESTING, IT WAS DISCOVERED THAT DXH 800/SMS SOFTWARE VERSION 3.0.2.0 AND DXH 600 SOFTWARE VERSION 1.1.1.0 ALLOW MULTIPLE ORDERS WITH SAME SPECIMEN ID (IDENTIFIER), BUT DIFFERENT PATIENT IDENTIFICATION WHEN EDITING ACTIVE ORDERS. THERE WERE NO PATIENT SAMPLES OR RESULTS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759468 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1