BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH-3ULTRA (TSH3-UL)

    MDR report key: 9291258 · Received November 7, 2019

    Report

    Report Number
    1219913-2019-00222
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 17, 2019
    Report Date
    November 21, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    00630414535654
    PMA / PMN Number
    K150403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2019-00222 ON NOVEMBER 07, 2019. THE CUSTOMER COMPLAINED OF A DISCORDANT RESULT ON ONE PATIENT SAMPLE IN THE ADVIA CENTAUR TSH3 ULTRA ASSAY. INTERNAL TESTING COULD NOT BE PERFORMED BECAUSE THE PATIENT SAMPLE COULD NOT BE SENT TO SIEMENS DUE TO PATIENT RIGHTS. THE MOST LIKELY CAUSE OF THE LOW TSH3 ULTRA RESULT FOR THIS PATIENT SAMPLE IS DESCRIBED IN THE LIMITATIONS SECTION OF THE ADVIA CENTAUR TSH3 ULTRA INSTRUCTIONS FOR USE (IFU): "AS WITH ANY IMMUNO-RECOGNITION MEASUREMENT OF A PEPTIDE, EXTREMELY RARE GENETIC VARIANTS MAY EXHIBIT VARYING DEGREES OF DETECTION". THERE IS NO PRODUCT ISSUE. THE ISSUE IS SAMPLE SPECIFIC. THE CUSTOMER REQUIRES NO FURTHER SUPPORT FROM SIEMENS ON THIS COMPLAINT. MDR 1219913-2019-00221 SUPPLEMENTAL REPORT 1 AND MDR 1219913-2019-00223 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TSH3-UL RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. MDR 1219913-2019-00221 AND MDR 1219913-2019-00223 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE AND THE ADVIA CENTAUR XP TSH ASSAY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085795 ADVIA CENTAUR XP TSH-3ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 63203335 00630414535654

    Patients

    Seq Age Sex Outcome Treatment
    1