BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2194407 · Received August 8, 2011

    Report

    Report Number
    2247117-2011-00046
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CKG
    PMA / PMN Number
    P010050/S012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) EVALUATED THE IMMULITE 2000 XPI INSTRUMENT AND INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATES THAT THE CAUSE OF THE DISCORDANT CALCITONIN AND ACTH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT IMMULITE 2000 XPI CALCITONIN AND ACTH RESULTS WERE GENERATED ON TWO PATIENT SAMPLES. BOTH SAMPLES WERE REPEATED FOR CONFIRMATION. DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT CALCITONIN AND ACTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 XPI IMMUNO-ASSAY CKG SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1