BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY

    MDR report key: 7356016 · Received March 20, 2018

    Report

    Report Number
    1219913-2018-00114
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 27, 2017
    Report Date
    October 5, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00114 ON MARCH 20, 2018. 09/21/2018 ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED. MULTIPLE SAMPLES WERE RECEIVED BY SIEMENS AND TESTED WITH MULTIPLE INVESTIGATIONAL PROTOCOLS. THE RESULTS OF THESE INVESTIGATIONS HAVE BEEN SUMMARIZED BELOW: EHIV LOT 103232. CHIV LOT 117142. SAMPLE ID: DRAW DATE: RLU : DOSE: RLU: DOSE: (B)(6), (B)(6) 2017, 1111774, >ASSAY RANGE, 13975 , 0.741. (B)(6), (B)(6) /2017, 1751924, >ASSAY RANGE, 12155, 0.616. (B)(6), (B)(6) 2018, 1377393, >ASSAY RANGE, 26082, 1.54. (B)(6), (B)(6) 2018, 1352312, >ASSAY RANGE , 31308, 1.87. (B)(6), (B)(6) 2018, 98332, 3.41, 33208 , 1.99. (B)(6), (B)(6) 2018, 1094192, >ASSAY RANGE, 31309 , 1.87. SAMPLE (B)(6) WAS TESTED WITH SEPARATE COMPONENTS OF THE ADVIA CENTAUR EHIV AND ADVIA CENTAUR CHIV ASSAY. THE SAMPLE SHOWED REACTIVITY TO THE CHIV HIV-1 AND P24 PORTIONS OF THE ASSAY. THE SAMPLES MAY HAVE UNEXPECTED RESULTS DUE TO THE PRESENCE OF P24 ANTIBODIES. THE PRIMARY PURPOSE OF THE ADVIA CENTAUR CHIV ASSAY IS TO AID IN THE DIAGNOSIS OF HIV INFECTION. CHIV ASSAY IS A COMBO ASSAY, IT ONLY HAS THE ARCHITECTURE TO DETECT P24 ANTIGEN. EHIV ASSAY IS ABLE TO DETECT THE PATIENT SAMPLE BECAUSE IT HAS THE ASSAY ARCHITECTURE FOR P24 AB DETECTION. THE DATA PROVIDED IN THE PROPOSED SCIENTIFIC PAPER (TITLED: INCONSISTENT DETECTION OF AN EVOLVING HIV INFECTION BY A POPULAR HIGH-THROUGHPUT SCREENING ASSAY FROM THE JOURNAL OF CLINICAL VIROLOGY) HAS BEEN REVIEWED. BASED ON THE DATA PROVIDED IN TABLE 1 OF THE PAPER, NO METHODS TESTED ON 3/11/2016 DETECT HIV. THE ADVIA CENTAUR CHIV ASSAY WAS REACTIVE FOR ANTIBODIES TO HIV-1/HIV-2 AND/OR P24 ANTIGEN ON (B)(6) 2017 ALONG WITH OTHER METHODS. THE INTENDED USE OF THE ADVIA CENTAUR CHIV ASSAY, AS STATED IN THE ASSAY IFU (10629832_EN REV. J, 2014-08): "THE ADVIA CENTAUR® HIV AG/AB COMBO (CHIV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE SIMULTANEOUS QUALITATIVE DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS P24 ANTIGEN AND ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUSES TYPE 1 (INCLUDING GROUP "O") AND TYPE 2, IN SERUM AND PLASMA (POTASSIUM-EDTA) TO AID IN THE DIAGNOSIS OF HIV INFECTION, USING THE ADVIA CENTAUR, ADVIA CENTAUR XP, AND ADVIA CENTAUR XPT SYSTEMS." IN THE LIMITATIONS SECTION OF THE IFU, IT STATES "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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00115 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00116 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00117 SUPPLEMENTAL REPORT 1, AND MDR 1219913-2018-00118 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE LIMITATIONS SECTION: "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. 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." MDR 1219913-2018-00115, MDR 1219913-2018-00116, MDR 1219913-2018-00117, AND MDR 1219913-2018-00118 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    (B)(6) RESULTS WERE OBTAINED ON FIVE SAMPLES FROM THE SAME PATIENT OVER A PERIOD OF TIME. THE PATIENT WAS REACTIVE BY OTHER METHODS AND PCR. THE PATIENT IS KNOWN TO BE (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197247 ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 88814109

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR