BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2162539 · Received July 14, 2011

    Report

    Report Number
    2247117-2011-00041
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FSE (FIELD SERVICE ENGINEER) WAS SENT TO THE CUSTOMER SITE. THE FSE COMPLETED AN INSPECTION WHICH INCLUDED CHECKING DISPENSE VOLUMES, SPINNER SPEEDS (BOTH WASH AND DILUTION WELL), TEMPERATURES AND SAMPLE AND REAGENT PIPETTOR POSITIONS. THE FSE ALSO RAN A PRECISION RUN ON GASTRIN USING ALL THREE LEVELS OF CONTROLS. THE PRECISION RESULTS WERE WITHIN SPECIFICATIONS. AFTER ANALYSIS OF THE SYSTEM AND SYSTEM DATA, THE ACTUAL CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CAUSED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW GASTRIN (GAS) RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE ON AN IMMULITE 2000. THE LABORATORY QUESTIONED THE INITIAL LOW RESULT AND THE SAMPLE WAS RE-TESTED TWICE. THE REPEAT GAS RESULTS WERE HIGHER AND WERE REPORTED. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GAS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1