BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 549542 · Received April 7, 2004

    Report

    Report Number
    2247117-2004-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2004
    Date of Event
    March 23, 2004
    Report Date
    April 1, 2004
    Manufacturer
    DPC INSTRUMENT SYSTEMS DIVISION
    Product Code
    JJQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DISCORDANT RESULTS. DURING THE TIME THE INVESTIGATION INTO THE PROBLEM BY THE FIELD SERVICE ENGINEER, HE DISCOVERED THAT THE KNF PUMP WAS NOT WORKING PROPERLY. AFTER THE INSTRUMENT WAS REPAIRED APPROXIMATELY 700 PATIENT SAMPLES WERE RETESTED. OF THESE 70-75 RESULTS HAD TO BE CHANGED. THE ORIGINAL RESULTS HAD BEEN REPORTED. THEREFORE SOME PATIENTS HAD UNDERGONE UNNECCESSARY PROCEDURES (NON-SURGICAL), SOME PATIENTS WERE REFERRED TO ONCOLOGISTS, AND SOME HAD THEIR MEDICATIONS ALTERED. NO ADVERSE EVENTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *