BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)

    MDR report key: 4191127 · Received October 21, 2014

    Report

    Report Number
    1219913-2014-00247
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    PMA / PMN Number
    K083844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00247 ON SEPTEMBER 24, 2014 REGARDING A NON-REPRODUCIBLE ADVIA CENTAUR XP TSH3 ULTRA RESULT. (B)(6) 2014: THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL TESTING OF THE SAMPLE. (B)(6) 2014 N- ALTERNATE INSTRUMENT ((B)(4)): TSH REPLICATE 1 2.10 UIU/ML; TSH REPLICATE 2 2.25 UIU/ML; TSH3UL REPEAT TESTING 2.154 UIU/ML. (B)(6) 2014: ORIGINAL INSTRUMENT (B)(4): TSH3UL 2.087 UIU/ML.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT, NON-REPRODUCIBLE ADVIA CENTAUR XP TSH3-ULTRA RESULT IS UNKNOWN. A SIEMENS CUSTOMER SERVICE ENGINEER WENT ON SITE. THE SAMPLE PROBE AND REAGENT PROBE ALIGNMENT WAS CHECKED AS WELL AS THE ACID AND BASE DISPENSE. THE PERFORMANCE OF THE WASH STATION AND LUMINOMETER WAS CHECKED. THE CUVETTE LOADER IONIZER WAS CLEANED. THE ASSAY WAS CALIBRATED AND QUALITY CONTROL MATERIAL WAS TESTED. RESULTS WERE WITHIN RANGE AND SHOWED GOOD PRECISION. THE INSTRUMENT IS OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A LOW ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) RESULT COMPARED TO REPEAT TESTING ON THE ADVIA CENTAUR XP TSH3-ULTRA ASSAY. THE CUSTOMER QUESTIONED THE LOW ADVIA CENTAUR TSH3-ULTRA RESULT AND PERFORMED REPEAT TESTING. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-UL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670278 ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 114275

    Patients

    Seq Age Sex Outcome Treatment
    1