BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000

    MDR report key: 1960503 · Received January 13, 2011

    Report

    Report Number
    2247117-2011-00003
    Date Received
    January 13, 2011
    Date of Event
    October 21, 2010
    Report Date
    December 28, 2010
    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
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA BY A SIEMENS TECHNICAL SERVICE ENGINEER (TSE) INDICATED THAT THERE WERE NO KNOWN CAUSES WHICH MAY HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 CALCITONIN RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW CALCITONIN (CAL) RESULTS WERE OBTAINED ON IMMULITE 2000 FOR TWO (2) PATIENT SAMPLES, DRAWN FROM THE SAME PATIENT ON DIFFERENT DATES. AN INITIAL LOW RESULT WAS OBTAINED FOR A SAMPLE DRAWN ON (B)(6) 2010. A HIGH RESULT WAS OBTAINED FOR A SECOND SAMPLE DRAWN ON (B)(6) 2010 (X100 DILUTION). THE LABORATORY SUBSEQUENTLY RE-TESTED THE INITIAL SAMPLE, WHICH HAD BEEN STORED FROZEN, AND OBTAINED A HIGH RESULT. (X100 DILUTION). ALL RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCITONIN RESULTS.

    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 50 YR