BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000 ANALYZER

    MDR report key: 478451 · Received August 11, 2003

    Report

    Report Number
    2247117-2003-00002
    Date Received
    August 11, 2003
    Date of Event
    July 1, 2003
    Report Date
    August 11, 2003
    Manufacturer
    DPC INSTRUMENT SYSTEMS DIVISIONS
    Product Code
    JJQ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC PRODUCTS CORP BECAME AWARE OF THIS INCIDENT WHEN IT WAS REPORTED TO A TECHNICAL SERVICE REP IN 07/03. THE SYSTEM MALFUNCTION WAS A BEAD SENSOR FAILURE THAT MAY RESULT IN TWO BEADS BEING DISPENSED INTO A SINGLE REACTION TUBE WITHOUT DETECTION. THIS CAN POSSIBLY CAUSE AN ERRONEOUS RESULT. THIS SYSTEM ERROR WAS CAUSED BY A SENSOR FAILURE. FOR THIS SENSOR FAILURE, POST PROCESSING OF THE DATA SHOWS THAT SOFTWARE VERSION 2.6A WOULD HAVE GREATLY REDUCED THE NUMBER OF REACTION TUBES WITH TWO BEADS FROM 151 TO A WORST CASE OF 11, BUT WOULD NOT HAVE TOTALLY ELIMINATED THE IMPACT OF THE FAILED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ANALYZER AUTOMATED ANALYZER FOR IVD USE. JJQ DPC INSTRUMENT SYSTEMS DIVISIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *