BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2898358 · Received January 7, 2013

    Report

    Report Number
    2247117-2013-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (08/23/13): THE DISCORDANT, FALSELY LOW ANTI-THYMOCYTE GLOBULIN (ATG) RESULT OBTAINED ON ONE PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT (S/N (B)(4)) WAS AN ISOLATED EVENT. THERE ARE NO REPORTS OF ADDITIONAL ATG DISCORDANT RESULTS OBTAINED ON THE INSTRUMENT. THE IMMULITE 2000 ATG ASSAY HAS MET ALL OF ITS MANUFACTURING SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW ATG RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY LOW ATG RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ANTI-THYMOCYTE GLOBULIN (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT. THE CUSTOMER HAD RUN SAMPLE COMPARISONS ON IMMULITE 2000 INSTRUMENTS. ONE PATIENT SAMPLE EXCEEDED THE ALLOWABLE PERCENT DIFFERENCE OF TWENTY-FIVE PERCENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW ATG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8187 IMMULITE 2000 IMMULITE 2000 JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1