BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY

    MDR report key: 12774953 · Received November 8, 2021

    Report

    Report Number
    1219913-2021-00483
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 29, 2021
    Report Date
    January 20, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00483 ON 2021-11-08. ADDITIONAL INFORMATION, 2022-01-12: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED SATES OBSERVED DISCORDANT NONREACTIVE (NEGATIVE) RESULTS WHEN USING THE ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY. THE CUSTOMER OBSERVED A NONREACTIVE CHIV RESULT FOR ONE PATIENT SAMPLE WHICH WAS REACTIVE WHEN TESTED BY AN ALTERNATE METHOD. QUALITY CONTROL (QC) WAS IN RANGE AT THE TIME OF THE EVENT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PRODUCED ANOTHER NONREACTIVE CHIV RESULT, INDICATING THAT THIS IS A SAMPLE/PATIENT SPECIFIC INCIDENT. A SAMPLE FROM THIS PATIENT WAS SENT FOR VIRAL LOAD TESTING AND A POSITIVE RESULT WAS OBTAINED. SIEMENS OBTAINED A SAMPLE FROM THE AFFECTED PATIENT FOR ADDITIONAL INVESTIGATION. THE SAMPLE WAS TESTED IN TRIPLICATE USING ADVIA CENTAUR CHIV AND ADVIA CENTAUR HIV 1/O/2 ENHANCED (EHIV) ASSAYS. SIEMENS' CHIV RESULTS REPRODUCED THOSE OF THE CUSTOMER OBSERVATION: ALL THREE REPLICATES MEASURED AS NONREACTIVE WITH AN INDEX ~ 0.6. ON THE EHIV METHOD, ALL THREE REPLICATES WERE REACTIVE WITH AN INDEX >50. IT IS NOTED THAT THE EHIV METHOD DETECTS P24 ANTIBODY WHICH IS LIKELY ELEVATED IN THIS SAMPLE CAUSING IT TO BE REACTIVE IN THE ALTERNATE METHODS. THE CHIV METHOD DETECTS THE P24 ANTIGEN, AND NOT THE ANTIBODY TO P24. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER LIMITATIONS: "THE CALCULATED VALUES FOR ANTI-HIV AND/OR P24 ANTIGEN IN A GIVEN SPECIMEN AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. THE REPORTED ANTIBODY LEVEL AND/OR P24 ANTIGEN CANNOT BE CORRELATED TO AN ENDPOINT TITER." A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO ADDITIONAL ACTION IS REQUIRED. IN SECTION H6, THE CODES FOR TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED BASED ON THE INVESTIGATION RESULTS. MDR 1219913-2021-00483 SUPPLEMENTAL 1 AND MDR 1219913-2021-00482 SUPPLEMENTAL 1 HAVE BEEN FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED DISCORDANT (B)(6) RESULTS WHEN USING THE HIV AG/AB COMBO (CHIV) ASSAY ON THE ADVIA CENTAUR CP. SIEMENS IS INVESTIGATING THIS EVENT. THE LIMITATIONS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "CURRENTLY AVAILABLE ASSAYS FOR THE DETECTION OF P24 ANTIGEN AND/OR ANTIBODIES TO HIV-1 AND/OR HIV-2 MAY NOT DETECT ALL INFECTED INDIVIDUALS. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HIV. HIV ANTIBODIES AND/OR P24 ANTIGEN MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS." "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." THIS REPORT ADDRESSES THE REPEAT OBSERVATION OF (B)(6) 2021. MDR 1219913-2021-00482 WAS FILED FOR THE INITIAL TEST RESULT OBTAINED ON (B)(6) 2021.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCORDANT (B)(6) RESULTS WHEN USING THE ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY. ON (B)(6) 2021, A PATIENT WAS TESTED FOR (B)(6) USING AN ALTERNATE METHOD, AND PRODUCED A (B)(6) RESULT. PER LABORATORY PROTOCOL, THIS SAMPLE WAS RE-TESTED USING THE ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY ON THE ADVIA CENTAUR CP; THIS RESULT WAS (B)(6). A NEW SAMPLE WAS DRAWN, AND ADDITIONAL TESTING WAS PERFORMED (B)(6) 2021. THE ALTERNATE METHOD AGAIN PRODUCED A (B)(6) RESULT, AND THE (B)(6) RESULT ON THE ADVIA CENTAUR CP WAS (B)(6) AGAIN. ADDITIONALLY, MOLECULAR VIRAL-LOAD TESTING CONFIRMED THE (B)(6). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673691 ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY HIV AG/AB DETECTION IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 292

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male