BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)

    MDR report key: 6768131 · Received August 4, 2017

    Report

    Report Number
    1219913-2017-00165
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 7, 2017
    Report Date
    October 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    00630414535647
    PMA / PMN Number
    K150403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00165 ON 08/04/2017 FOR A FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) PATIENT RESULT. 08/16/17 - ADDITIONAL INFORMATION: SIEMENS HAS TESTED THE RETURN PATIENT SAMPLE, AND THE RESULTS ARE CONSIDERED TO BE NORMAL. THE PATIENT SAMPLE WAS RECEIVED THAWED, WITH NO ICE PACK. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR INVESTIGATION. SIEMENS TEST RESULTS OF THE RETURNED CUSTOMER SAMPLE. ADVAI CENTAUR XP ASSAY: LOT : RESULT: TSH3UL, 114301, 1.206 UIU/; TSH3UL, 114297, 1.188 UIU/ML; TSH, 001281, 1.40 UIU/ML; FT4, 113080, 0.81 NG/DL.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00165 ON 08/04/2017 FOR A FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) PATIENT RESULT, AND MDR 1219913-2017-00165 SUPPLEMENTAL REPORT 1 ON 08/31/2017 FOR ADDITIONAL INFORMATION (RETURNED SAMPLE RESULTS). 09/11/17 - ADDITIONAL INFORMATION: PATIENT'S PREEXISTING MEDICAL CONDITIONS: MALIGNANT THYROID TUMOR POST-SURGICAL HYPOTHYROIDISM BASED ON THE LOW TSH REPORTS. THE PATIENT HAS BEEN TESTED SINCE 2013 (RESULTS NOT PROVIDED). PATIENT'S MEDICATIONS: THYROXINE, AMLODIPINE BESYLATE, MICARDIS-80, PLAVIX, METOPROLOL TARTRATE. 09/27/17 - ADDITIONAL INFORMATION: THE RESULTS OBTAINED BY SIEMENS FROM THE RETURNED SAMPLE (REPORTED IN MDR SUPPLEMENTAL REPORT 1) WERE OBSERVED TO BE NORMAL ON BOTH THE ADVIA CENTAUR TSH AND ADVA CENTAUR TSH3 ULTRA ASSAYS. SIEMENS DID NOT OBSERVE THE SAME LOW RESULT THAT THE CUSTOMER REPORTED. THE CAUSE FOR THE FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) PATIENT RESULT IS UNKNOWN, AND MAY BE ATTRIBUTED TO THE DIFFERENCES IN MEDICATIONS THE PATIENT IS TAKING OR SAMPLE PREPARATION/SAMPLE STORAGE. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) 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." THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATION SECTION: "AS WITH ANY IMMUNO-RECOGNITION MEASUREMENT OF A PEPTIDE, EXTREMELY RARE GENETIC VARIANTS MAY EXHIBIT VARYING DEGREES OF DETECTION."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING, AND HAS REQUESTED THE PATIENT SAMPLE FOR TESTING. THE INSTRUCTION FOR USE (IFU) 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." THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATION SECTION: "AS WITH ANY IMMUNO-RECOGNITION MEASUREMENT OF A PEPTIDE, EXTREMELY RARE GENETIC VARIANTS MAY EXHIBIT VARYING DEGREES OF DETECTION."

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN WAS EXPECTING A HIGHER TSH VALUE, AND QUESTIONED THE RESULT. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED ON AN ALTERNATE TSH TEST METHOD, AND THE RESULT WAS HIGHER. THE PHYSICIAN SUSPECTS A POTENTIAL SAMPLE INTERFERENT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548464 ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY, JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 114297 00630414535647

    Patients

    Seq Age Sex Outcome Treatment
    1