BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1963202 · Received January 18, 2011

    Report

    Report Number
    2122870-2011-00099
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS BEEN PERFORMING WITHIN RANGE. PROCESS MONITORING IS USED TO DETECT LOW OR EMPTY WELLS WITHIN THE REAGENT PACK, WHEN ASPIRATING REAGENT COMPONENTS DURING PATIENT TESTING. DXI SOFTWARE VERSION 4.1 AND ABOVE INCORPORATED THIS PROCESS MONITORING FEATURE TO PREVENT REAGENT PACK SHARING BETWEEN INSTRUMENTS BY USING A DISPENSE RATIO ALGORITHM A/E TO DETECT INSUFFICIENT REAGENT VOLUMES, THAT COULD PRODUCE ERRONEOUS RESULTS IF UNDETECTED. THE HIV COMBO REAGENT COMPONENT IN WELL #1 HAS A VISCOSITY THAT CAN CAUSE THE A/E RATIO TO FAIL, AND CAN GENERATE REAGENT PACK MONITORING FAILED TO INITIALIZE YELLOW ICON WARNINGS TO THE USER. SERVICE HAS NOT BEEN DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING INTERMITTENT, BUT FREQUENT "REAGENT PACK MONITORING FAILED TO INITIALIZE" ERRORS DURING ASPIRATION FROM WELL #1, WHEN RUNNING THE ACCESS HIV COMBO REAGENT KIT ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. NO ERRONEOUS RESULTS HAVE BEEN GENERATED IN ASSOCIATION WITH THIS EVENT. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1