BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR THCG

    MDR report key: 23377831 · Received October 24, 2025

    Report

    Report Number
    1219913-2025-00197
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 1, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHA
    UDI-DI
    630414505176
    PMA / PMN Number
    K200210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR WAS INITIALLY FILED ON 24-OCT-2025. ADDITIONAL INFORMATION (05-NOV-2025): SIEMENS CONCLUDED INVESTIGATION FOR A CUSTOMER COMPLAINT OF OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA, THE INFORMATION PROVIDED BY THE CUSTOMER, AND THE INSTRUMENT PERFORMANCE, WHICH INCLUDED THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) TOTAL SERVICE VISIT. NO INSTRUMENT ISSUES WERE OBSERVED. REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QC RECOVERY AND PRECISION WITHIN ACCEPTABLE RANGES, NO ERRORS WERE POSTED IN THE EVENT LOG, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT WAS UNABLE TO BE DETERMINED. THE ISSUE WAS ISOLATED TO THE AFFECTED PATIENT SAMPLE. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. CUSTOMER IS OPERATIONAL; NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. QUALITY CONTROL (QC) RECOVERED WITHIN THE LABORATORY ESTABLISHED RANGES. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING KIT LOT 363. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL ANALYZER WHICH OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE PATIENT¿S CLINICAL DIAGNOSIS AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504835 ADVIA CENTAUR THCG ADVIA CENTAUR THCG DHA SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 90851363 630414505176

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female