BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9225190 · Received October 23, 2019

    Report

    Report Number
    1219913-2019-00220
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 16, 2019
    Report Date
    February 4, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2019-00220 ON OCTOBER 23, 2019. 01/23/2020 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RECEIVED BY SIEMENS AND TESTED ON BOTH THE ADVIA CENTAUR CP AND ATELLICA IM PLATFORMS. THE RESULTS HAVE BEEN SUMMARIZED BELOW: ADVIA CENTAUR CP CHIV LOT 117232: 1.29, INDEX. ATELLICA IM CHIV LOT 117233: 1.36, INDEX. ATELLICA IM EHIV LOT 103264: 20.4, INDEX. THE SAMPLE WAS THEN TESTED IN SEPARATE SOLID PHASE COMPONENTS OF THE EHIV AND CHIV ASSAY. THE SAMPLE WAS HIGHLY REACTIVE WITH THE EHIV P24 ANTIBODY PORTION OF THE SOLID PHASE AND WAS NONREACTIVE WITH CHIV P24 ANTIGEN PORTION OF THE SOLID PHASE. THE DECREASING INDEX ON OBSERVED WITH THE CHIV ASSAY ON THE ADVIA CENTAUR CP AND ATELLICA IM IS BECAUSE OF THE NEUTRALIZATION OF THE P24 ANTIGEN. EHIV HAS A DIFFERENT ASSAY ARCHITECTURE AND DETECTS P24 ANTIBODY. BASED ON THE RESULTS GENERATED BY SIEMENS, THE OBSERVATION OF A NON-REACTIVE RESULTS WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE, NO PRODUCT PROBLEM IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2019-00219 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP CHIV 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 CLINICALCONDITIONS."MDR 1219913-2019-00219 (10/14/2019 INITIAL RESULT) WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR CP HIV AG/AB COMBO AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON (B)(6) 2019. THE SAME SAMPLE WAS PREVIOUSLY TESTED ON THE ATELLICA IM SYSTEM ON (B)(6) 2019; AND THE RESULTS WERE (B)(6). THE CUSTOMER HAD REPEATED THE SAMPLE ON THE ADVIA CENTAUR CP BECAUSE THE VALUES FOR THE ATELLICA IM RESULT HAD DECREASED IN COMPARISON TO THE VALUES OF A PREVIOUS SAMPLE THAT WAS TESTED ON (B)(6) 2019. THE CUSTOMER REPEATED THE SAMPLE ON THE ADVIA CENTAUR CP ON (B)(6) 2019 AND THE RESULT WAS (B)(6). THE CUSTOMER REPORTED THE (B)(6) RESULT FROM THE ATELLICA IM SYSTEM. THE CUSTOMER HAD PROCESSED VIRAL CHARGE ON AN ALTERNATE METHOD FOR THE PREVIOUS SAMPLE WITH A RESULT OF 10^6 AND WESTERN BLOT: P24, P31, GP160, GP140 AND GP36 WERE (B)(6) AND GP41 (B)(6). THE CUSTOMER REPORTED THE RESULT AS INDETERMINATE AND ASKED FOR A NEW SAMPLE. THE CUSTOMER PROCESSED VIRAL CHARGE ON THE SECOND SAMPLE WITH A RESULT OF 10^4 AND WESTERN BLOT: (B)(6) FOR ALL EXCEPT GP140 AND GP36 THAT WERE (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP CHIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017242 ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY CHIV ASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 66007201

    Patients

    Seq Age Sex Outcome Treatment
    1