BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 24889473 · Received April 15, 2026

    Report

    Report Number
    1219913-2026-00079
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    SEI
    UDI-DI
    000630414591407
    PMA / PMN Number
    P100039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF FALSE REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 174 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DIFFERENT REAGENT LOT 176. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF FALSE REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 174 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DIFFERENT REAGENT LOT 176. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER WITH SAME REAGENT LOT, AGAIN YIELDING A REACTIVE RESULT. THE SAME SAMPLE WAS THEN REPROCESSED TWICE ON AN ALTERNATE ADVIA CENTAUR XP ANALYZER USING ANOTHER REAGENT LOT, AND BOTH RUNS PRODUCED NON-REACTIVE RESULTS. THE NONREACTIVE RESULTS WERE CONSIDERED CORRECT, AS THEY WERE IN AGREEMENT WITH THE PATIENT'S CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE REACTIVE AHBS2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158827 ADVIA CENTAUR ADVIA CENTAUR ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) SEI SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 41082174 000630414591407

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female