BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HBSAGII (HBSII)

    MDR report key: 12739542 · Received November 2, 2021

    Report

    Report Number
    1219913-2021-00473
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    September 1, 2021
    Report Date
    April 29, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414578170
    PMA / PMN Number
    P110041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-000473 INITIAL REPORT ON 2021-11-02. ADDITIONAL INFORMATION - 2022-04-05 SIEMENS COMPLETED INVESTIGATION FOR A CUSTOMER OBSERVATION OF FALSE NEGATIVE ADVIA CENTAUR XP HBSAGII (HBSII) RESULTS FROM ONE PATIENT. THE CALIBRATION AND CONTROLS RESULTS WERE WITHIN EXPECTED RANGES. SIEMENS REVIEWED THE CALIBRATION DATA PROVIDED AND FOUND NO INDICATION OF AN ISSUE. THE CUSTOMER HAD A SAMPLE FROM A PATIENT WITH A HISTORY OF POSITIVE HEPATITIS B RESULTS THAT RECOVERED NONREACTIVE (0.63 INDEX) WITH ADVIA CENTAUR XP HBSAGII (HBSII) KIT LOT 253 BUT WAS PCR REACTIVE (60 UI/ML). THE SAMPLE WAS ALSO ANTI-HBS REACTIVE, HBEAG NONREACTIVE, AND ANTI-HBE REACTIVE. THE ORIGINAL SAMPLE WAS NOT RETESTED TO VERIFY THE PCR RESULT AND NO INFORMATION WAS PROVIDED ON WHETHER THE SAMPLE WAS RETESTED TO VERIFY THE ADVIA CENTAUR XP HBSII RESULT. A NEW SAMPLE FROM THE SAME PATIENT COLLECTED A MONTH LATER HAD NO DETECTABLE HEPATITIS B VIRUS (HBV) DEOXYRIBONUCLEIC ACID (DNA). WHEN THE PATIENT WAS TESTED IN 2020, THE SAMPLE RECOVERED NONREACTIVE (0.8 INDEX) WITH THE ADVIA CENTAUR XP HBSII ASSAY BUT THERE IS NO PCR RESULT AVAILABLE. THERE IS NO SAMPLE REMAINING FOR THIS PATIENT THAT CAN BE SENT TO SIEMENS FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION THE NONREACTIVE HBSII RESULT MAY BE ACCURATE. A SEARCH OF THE COMPLAINT DATABASE FOUND NO OTHER COMPLAINTS FOR FALSE NEGATIVES WITH ADVIA CENTAUR XP/XPT HBSII LOT 253. FIELD DATA INDICATES AT LEAST 4000 POSITIVES SAMPLES HAVE BEEN TESTED WITH ADVIA CENTAUR XP/XPT HBSII LOT 253. THE SENSITIVITY SECTION OF THE ADVIA CENTAUR XP/XPT HBSII INSTRUCTIONS FOR USE (IFU) (1063515) LISTS THE 95% CONFIDENCE INTERVAL (CI) FOR SENSITIVITY AS 99.09% - 100.00%. IF THIS ONE SAMPLE WAS A TRUE FALSE NEGATIVE, 1 FALSE NEGATIVE RESULT OUT OF 4000 POSITIVE RESULTS WOULD MEAN A SENSITIVITY OF 99.98% FOR LOT 253. BASED ON THIS INFORMATION ADVIA CENTAUR XP HBSII LOT 253 IS PERFORMING AS INTENDED. PLEASE NOTE THAT AS STATED IN THE LIMITATIONS SECTION OF THE ADVIA CENTAUR XP/XPT HBSII INSTRUCTIONS FOR USE (IFU) (1063515), "IT IS RECOGNIZED THAT THE CURRENT METHODS FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN MAY NOT DETECT ALL POTENTIALLY INFECTED INDIVIDUALS. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HEPATITIS B. A NONREACTIVE TEST RESULT IN INDIVIDUALS WITH PRIOR EXPOSURE TO HEPATITIS B MAY BE DUE TO ANTIGEN LEVELS BELOW THE DETECTION LIMIT OF THIS ASSAY OR LACK OF ANTIGEN REACTIVITY TO THE ANTIBODIES IN THIS ASSAY." THE CAUSE OF THE NONREACTIVE RESULTS SEEN BY THE CUSTOMER WHEN USING ADVIA CENTAUR XP HBSII LOT 253 COULD NOT BE DETERMINED BUT SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL. NO FURTHER ACTION IS NEEDED. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS. MDR 1219913-2021-00474 SUPPLEMENTAL 1 REPORT WAS FILED FOR THE SAME COMPLAINT.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSE NEGATIVE ADVIA CENTAUR XP HBSAGII (HBSII) RESULT. SIEMENS IS INVESTIGATING. CUSTOMER CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "IT IS RECOGNIZED THAT THE CURRENT METHODS FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN MAY NOT DETECT ALL POTENTIALLY INFECTED INDIVIDUALS. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HEPATITIS B. A NONREACTIVE TEST RESULT IN INDIVIDUALS WITH PRIOR EXPOSURE TO HEPATITIS B MAY BE DUE TO ANTIGEN LEVELS BELOW THE DETECTION LIMIT OF THIS ASSAY OR LACK OF ANTIGEN REACTIVITY TO THE ANTIBODIES IN THIS ASSAY." "PATIENTS TAKING BIOTIN SUPPLEMENTS MAY HAVE FALSE NEGATIVE RESULTS WITH THIS ASSAY. PATIENT SAMPLES CONTAINING BIOTIN OF GREATER THAN 75 NG/ML MAY PRODUCE FALSE NEGATIVE RESULTS." "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR HBSAGII TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS." MDR 1219913-2021-00474 WAS FILED FOR THE 2020 FALSE NEGATIVE RESULT.

    Description of Event or Problem · 0

    A CUSTOMER INFORMED SIEMENS HEALTHCARE DIAGNOSTICS THAT THEY OBTAINED A NON-REACTIVE (NEGATIVE) ADVIA CENTAUR XP HBSAGII (HBSII) RESULT FOR A (B)(6) FEMALE PATIENT ON (B)(6) 2021. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE RESULT DOES NOT MATCH THE PATIENT'S CLINICAL HISTORY, WHERE RESULTS HAVE BEEN REACTIVE SINCE 2016, EXCEPT FOR ONE OTHER INSTANCE IN 2020 WHERE A NON-REACTIVE RESULT WAS ALSO OBSERVED. REPEAT TESTING WAS PERFORMED USING AN ALTERNATE METHOD AND A REACTIVE (POSITIVE) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (NON-REACTIVE) HBSAGII RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637140 ADVIA CENTAUR HBSAGII (HBSII) HEPATITIS B VIRUS SURFACE ANTIGEN IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 253 00630414578170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female