BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 8501222 · Received April 10, 2019

    Report

    Report Number
    2247117-2019-00027
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    February 20, 2019
    Report Date
    June 7, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2247117-2019-00027 ON 10-APR-2019. ADDITIONAL INFORMATION (15-MAY-2019): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) INVESTIGATED THE ISSUE AND FOUND THAT THE CUSTOMER IS USING IMMULITE 2000 - ANTI- TG AB (ATG) REAGENT KIT TO TEST FOR AUTO-IMMUNE DISEASE. ANTIBODY ASSAYS HAVE POOR CONCORDANCE AMONGST EACH OTHER. HSC EDUCATED THE CUSTOMER ON THE ISSUE AND PROVIDED ADDITIONAL LITERATURE TO THE CUSTOMER. THE CAUSE OF THE EVENT WAS UNINTENDED USE ERROR. THE METHOD, RESULTS, AND CONCLUSION CODE IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT, FALSELY DEPRESSED ANTI-TG AB (ATG) RESULTS THAT WERE OBTAINED USING AN IMMULITE 2000 INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDR 2247117-2019-00028 WAS FILED FOR THE OTHER IMMULITE 2000 INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT, FALSELY DEPRESSED ANTI-TG AB (ATG) RESULTS THAT WERE OBTAINED ON AN IMMULITE 2000 INSTRUMENT. IT IS UNKNOWN IF THE INITIAL DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON ANOTHER IMMULITE 2000 AT ANOTHER SITE AND THE REPEAT RESULT WAS FALSELY DEPRESSED. THE CUSTOMER INFORMED SIEMENS THAT THE ADJUSTMENT SLOPES AND QUALITY CONTROL SAMPLES WERE WITHIN SPECIFICATION FOR THE ATG ASSAY. THE SAMPLE WAS THEN RUN ON AN ALTERNATE PLATFORM (NON-SIEMENS PLATFORM) AND THE RESULT WAS HIGHER AND WAS AS EXPECTED. THE RESULT ON THE ALTERNATE PLATFORM WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293696 IMMULITE 2000 IMMULITE 2000 JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1