BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2334332 · Received November 14, 2011

    Report

    Report Number
    2247117-2011-00067
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LYR
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, IT WAS DETERMINED THAT THE PATTERN OF DATA INDICATED CONTAMINATION. THE CAUSE OF THE CONTAMINATION COULD NOT BE DETERMINED. THE FSE DECONTAMINATED THE SUBSTRATE RESERVOIR AND WATER LINES AND PROACTIVELY REPLACED PARTS IN THE SUBSTRATE DELIVERY LINE. IT WAS DETERMINED THAT THE CAUSE OF THE DISCORDANT, FALSELY HIGH HPG RESULTS WAS DUE TO CONTAMINATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY HIGH H. PYLORI IGG (HPG) RESULTS ON MULTIPLE PATIENT SAMPLES WERE GENERATED ON THE IMMULITE 2000. NO RESULTS WERE REPORTED. THE PATIENT SAMPLES WERE RE-TESTED AFTER ASSAY ADJUSTMENT AND HPG RESULTS WERE GENERATED THAT WERE LOWER THAN THE INITIAL RESULTS. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT, FALSELY HIGH HPG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMULITE 2000 LYR SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1