BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)

    MDR report key: 3642720 · Received February 24, 2014

    Report

    Report Number
    1219913-2014-00049
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    PMA / PMN Number
    K083844
    Removal / Correction Number
    1219913-04/11/2014-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00049 ON (B)(6) 2014. ON (B)(6) 2104, SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE ISSUE. THE INVESTIGATIONS HAVE CONFIRMED THAT SAMPLES CONTAINING FLUORESCEIN MAY SHOW INTERFERENCE WITH THE ADVIA CENTAUR SYSTEMS TSH3 ULTRA ASSAY. SAMPLES CONTAINING FLUORESCEIN CAN PRODUCE FALSELY DEPRESSED VALUES WHEN TESTED WITH THE ADVIA CENTAUR XP TSH3 ULTRA ASSAY. WITH FLUORESCEIN INTERFERENCE, OBSERVED TSH3 ULTRA VALUES CAN BE AS LOW AS <0.01 MIU/L. SAMPLES SHOULD BE RESUBMITTED POST FLUORESCEIN CLEARANCE TO ENSURE THERE IS NO INTERFERENCE WITH TSH3 ULTRA TEST RESULTS. AS A RESULT, AN URGENT MEDICAL DEVICE CORRECTION (B)(4) WAS SENT TO CUSTOMERS IN THE UNITED STATES AND AN URGENT FIELD SAFETY NOTICE (B)(4) WAS SENT TO CUSTOMERS OUTSIDE OF THE UNITED STATES IN (B)(6) 2014 TO INFORM THEM OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TSH3-ULTRA RESULT IS UNKNOWN. DILUTIONS ON THE PATIENT SAMPLE WERE PERFORMED ON THE ADVIA CENTAUR TSH AND THE ALTERNATE METHOD TSH ULTRA. THE RESULTS WERE LINEAR. THE DILUTION ON THE TSH3-UL FOR THE PATIENT SAMPLE WAS OVERDILUTED. HETEROPHILE BLOCKING REAGENT WAS ADDED TO THE PATIENT SAMPLE AND TESTED ON THE ADVIA CENTAUR TSH AND THE ALTERNATE METHOD TSH ULTRA. THIS DID NOT SIGNIFICANTLY ALTER THE RESULTS. THE QUALITY CONTROL WAS ACCEPTABLE ON THE DAY OF TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE TEST METHOD AND THE RESULT WAS AS EXPECTED. THE PREVIOUS PATIENT RESULT ON THE ADVIA CENTAUR XP IN (B)(6) WAS HIGHER. THE PATIENT WAS INFUSED WITH 5CC OF FLUORESCEIN VIA IV FORTY FIVE MINUTES BEFORE THE SAMPLE WAS TESTED FOR THYROID-STIMULATING HORMONE (TSH). THE SERUM SAMPLE WAS NOTED TO HAVE A GREEN FLUORESCENT TINGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114163 ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 270

    Patients

    Seq Age Sex Outcome Treatment
    1