BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP FT4

    MDR report key: 6208574 · Received December 28, 2016

    Report

    Report Number
    1219913-2016-00251
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 28, 2016
    Report Date
    February 21, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEC
    PMA / PMN Number
    K132249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1219913-2016-00251 WAS FILED ON DECEMBER 28, 2016 REPORTING A LOW ADVIA CENTAUR XP FT4 RESULT THAT DID NO REPRODUCE WITH REPEAT TESTING. FEBRUARY 7, 2017 - ADDITIONAL INFORMATION: SIEMENS RECEIVED THE SAMPLE FROM THE CUSTOMER AND TESTED IT IN REPLICATES OF THREE ON REAGENT LOT 073. THE RESULTS WERE: REPLICATE #1 0.80 NG/DL, REPLICATE #2 0.87 NG/DL, REPLICATE #3 0.83 NG/DL, MEAN 0.83 NG/DL. THESE RESULTS ARE SIMILAR TO THE CUSTOMER REPEAT RESULTS. THE MOST LIKELY CAUSE OF THE INITIAL LOW ADVIA CENTAUR XP FT4 RESULT IS SAMPLE PREPARATION OR HANDLING.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE NON-REPRODUCIBLE ADVIA CENTAUR XP FT4 RESULT IS UNKNOWN. SIEMENS VISITED THE CUSTOMER AND VERIFIED THE PERFORMANCE OF THE INSTRUMENT. THERE WERE NO ERRORS IN THE ERROR LOG AT THE TIME OF THE EVEN. ALL CALIBRATIONS AND QC WAS ACCEPTABLE. THE SAMPLE WAS TESTED AN ADDITIONAL 20 TIMES AND ALL RESULTS WERE BETWEEN 0.78 AND 0.80 NG/DL. SIEMENS HAS REQUESTED THE SAMPLE FOR ADDITIONAL TESTING. THE INSTRUCTIONS FOR USE STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A LOW ADVIA CENTAUR XP FT4 RESULT THAT DID NOT REPRODUCE WITH REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP FT4 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859740 ADVIA CENTAUR XP FT4 RADIOIMMUNOASSAY, FREE THYROXINE CEC SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 073

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR