BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 5128401 · Received October 5, 2015

    Report

    Report Number
    2247117-2015-00053
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    June 15, 2015
    Report Date
    October 13, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR 2247117-2015-00053 WAS FILED ON 10/52015. ADDITIONAL INFORMATION (10/13/2015): THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER INDICATED THAT BASED ON INTERFERENCE TESTING FOR HETEROPHILIC ANTIBODIES THE RESULTS HAVE BEEN DISCUSSED WITH THE LAB MANAGER WHO HAS ACCEPTED THE EXPLANATION FOR THE DISCORDANT LOW CALCITONIN RESULT. THE CUSTOMER HAS ALSO INDICATED THAT THE CALCITONIN ASSAY IS PERFORMING AS PER SPECIFICATIONS AND DOES NOT NEED ANY FURTHER ASSISTANCE ON THIS ISSUE. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY LOW CALCITONIN RESULT ON THE IMMULITE 2000 XPI INSTRUMENT IS UNKNOWN. SIEMENS HEALTHCARE IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBTAINED A FALSELY LOW RESULT ON PATIENT SAMPLE FOR THE CALCITONIN ASSAY ON AN IMMULITE 2000 XPI. THE SAME SAMPLE WAS RUN ON AN ALTERNATE PLATFORM AND THE RESULT WAS HIGHER. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN (S) AS IT DID NOT FIT THE CLINICAL PICTURE. THE RESULT ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW RESULT OBTAINED ON THE IMMULITE 2000 XPI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657630 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1