BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1984209 · Received February 10, 2011

    Report

    Report Number
    2122870-2011-00353
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, WHICH COULD PRODUCE ERRONEOUS RESULTS IF UNDETECTED. THE (B)(6) 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. THERE WAS NO REPORT OF ANY ERRONEOUS RESULTS 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1