BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII)

    MDR report key: 11824563 · Received May 14, 2021

    Report

    Report Number
    1219913-2021-00255
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414578170
    PMA / PMN Number
    P110041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD A SAMPLE FROM A (B)(6) MONTH OLD THAT RECOVERED (B)(6) WITH ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII) KIT LOT 228 BUT (B)(6) WITH TWO ALTERNATE METHODS. THE SAMPLE WAS ALSO: ATELLICA IM HBSII (B)(6) WITH KIT LOT 237. (B)(6). ALKALINE PHOSPHATASE (ALP): 316 / ASPARTATE AMINOTRANSFERASE (AST): 508 / ALANINE AMINOTRANSFERASE (ALT): 692 / GAMMA-GLUTAMYL TRANSFERASE (GGT): 189 / LACTATE DEHYDROGENASE (LDH): 549 (UNIT: U/L). SIEMENS REVIEWED THE CALIBRATION AND CONTROL DATA PROVIDED AND THERE IS NO EVIDENCE OF A PROBLEM. SIEMENS DOES NOT HAVE ANY INFORMATION INDICATING SUPRAX OR RAMNOS WOULD INTERFERE WITH THE ADVIA CENTAUR XPT HBSII ASSAY. THERE IS NO SAMPLE THAT CAN BE SENT TO SIEMENS FOR EVALUATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO OTHER COMPLAINTS ABOUT FALSE NEGATIVES WITH ADVIA CENTAUR XP/XPT HBSII LOT 228 OR ATELLICA IM HBSII KIT LOT 237. ACCORDING TO SMART REMOTE SERVICES (SRS) DATA MORE THAN 2,000 POSITIVES SAMPLES HAVE BEEN TESTED WITH ADVIA CENTAUR XP/XPT HBSII LOT 228 AND MORE THAN 86,000 POSITIVE SAMPLES HAVE BEEN TESTED WITH ATELLICA IM HBSII KIT LOT 237. THE SENSITIVITY SECTION OF THE ADVIA CENTAUR XP/XPTHBSII INSTRUCTIONS FOR USE (IFU) (10635152 REVISION K, 2020-08) STATES: "SENSITIVITY = 100% (403/403) 95% CI (CONFIDENCE INTERVAL) = 99.09-100.00%." BASED ON THIS INFORMATION ADVIA CENTAUR XP/XPT HBSII LOT 228 AND ATELLICA IM HBSII KIT LOT 237 ARE PERFORMING AS INTENDED SINCE 1 FALSE NEGATIVE RESULT OUT OF >2000 POSITIVE RESULTS WOULD MEAN A SENSITIVITY OF >99.95% FOR ADVIA CENTAUR XP/XPT HBSII LOT 228 AND 1 FALSE NEGATIVE RESULT OUT OF >86,000 POSITIVE RESULTS WOULD MEAN A SENSITIVITY OF >99.99% FOR ATELLICA IM HBSII LOT 237. THE LIMITATIONS SECTION OF THE ADVIA CENTAUR XP/XPT HBSII INSTRUCTIONS FOR USUE 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." THE MUTANT HBSAG DETECTION SECTION OF THE ADVIA CENTAUR XP/XPT HBSII IFU LISTS MUTATIONS THAT HAVE BEEN TESTED BUT OTHER MUTATIONS COULD LEAD TO FALSE NEGATIVE RESULTS AND STATES: "THE MUTATIONS OF DIAGNOSTIC CONCERN ARE THOSE THAT OCCUR IN THE SEQUENCE CODING FOR "A" DETERMINANT (AMINO ACIDS 124-147) WITHIN THE MAJOR HYDROPHILIC LOOP (AMINO ACIDS 100-170) OF THE HBV SURFACE ANTIGEN (HBSAG).13 ALL IMMUNOASSAYS FOR HBSAG HAVE ANTIBODIES THAT BIND IN THIS REGION AND AMINO ACID CHANGES IN THIS REGION CAN LEAD TO FALSE NEGATIVE RESULTS WHEN THESE CHANGES OCCUR AT SPECIFIC ANTIBODY BINDING SITES.14 THE PATIENT IS ANTI-HBS POSITIVE. IF THE PATIENT'S ANTIBODIES ARE BINDING HBSAG AT THE SAME SITES WHERE THE ANTIBODIES IN THE ADVIA CENTAUR HBSII ASSAY BIND, THEY COULD BLOCK THE ASSAY FROM DETECTING A SMALL QUANTITY OF HBSAG. THE CAUSE OF THE DISCREPANT RESULTS SEEN BY THE CUSTOMER WHEN USING ADVIA CENTAUR XP/XPT HBSII LOT 228 AND ATELLICA IM HBSII KIT LOT 237 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ADVIA CENTAUR XPT (B)(6) SURFACE ANTIGEN II ((B)(6)) RESULT FOR A PATIENT SAMPLE THAT WAS (B)(6) ON TWO ALTERNATE METHODS. THE (B)(6) RESULT DID NOT AGREE WITH THE CLINICAL PICTURE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XPT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722473 ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII) HEPATITIS B SURFACE ANTIGEN IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 228 00630414578170

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO