BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENATUR XP FT4

    MDR report key: 6138649 · Received December 1, 2016

    Report

    Report Number
    1219913-2016-00232
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 13, 2016
    Report Date
    January 25, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEC
    PMA / PMN Number
    K132249
    Removal / Correction Number
    1219913-01/10/2017-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00232 ON 12/01/2016 FOR LOW ADVIA CENTAUR XP FT4 PATIENT RESULTS OBTAINED WITH CALIBRATOR CAL A LOT 90, AND FT4 REAGENT LOTS. ON 01/05/2017 - ADDITIONAL INFORMATION: SIEMENS HAS PERFORMED AN INTERNAL INVESTIGATION AND HAS CONFIRMED A NEGATIVE BIAS FOR THE ADVIA CENTAUR FT4 WHEN USED WITH CALIBRATOR A KIT LOTS ENDING IN 90 ON THE ADVIA CENTAUR, ADVIA CENTAUR XP AND ADVIA CENTAUR XPT SYSTEMS. IN ADDITION, SIEMENS HEALTHCARE DIAGNOSTICS CONFIRMED THE POTENTIAL FOR CALIBRATION FAILURES DUE TO ABOVE LIMIT CALIBRATOR RLU %CVS WHEN USING CALIBRATOR A KIT LOTS ENDING IN 90 WITH THE FT4 ASSAY. SIEMENS ISSUED UFSN CC 17-04.A.OUS (JANUARY 2017) AND UMDR CC 17-04.A.US (JANUARY 2017) INFORMING THE CUSTOMER OF FT4 ASSAY NEGATIVE BIAS OBSERVED WITH CALIBRATOR A KIT LOTS ENDING IN 90. INSTRUCTIONS ON ACTIONS TO BE TAKEN ARE PROVIDED IN THE CUSTOMER COMMUNICATION. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE LOW ADVIA CENTAUR XP FT4 RESULTS OBSERVED BY THE CUSTOMER WITH CALIBRATOR CAL A LOT 90, AND FT4 REAGENT LOTS WHEN PERFORMING A FT4 REFERENCE RANGE CHECK IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." ADDITIONAL FT4 REAGENT LOT INFORMATION. LOT NUMBER: 113072, EXPIRATION DATE: 04/04/2017, DATE OF MANUFACTURER: 04/04/2016, (B)(4).

    Description of Event or Problem · 1

    LOW ADVIA CENTAUR XP FT4 RESULTS WERE OBSERVED BY THE CUSTOMER WITH CALIBRATOR CAL A LOT 90, AND FT4 REAGENT LOTS WHEN PERFORMING A FT4 REFERENCE RANGE CHECK. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER FT4 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790043 ADVIA CENATUR XP FT4 RADIOIMMUNOASSAY, FREE THYROXINE CEC SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 113071

    Patients

    Seq Age Sex Outcome Treatment
    1