BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14106955 · Received April 13, 2022

    Report

    Report Number
    1219913-2022-00110
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 18, 2022
    Report Date
    July 20, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE POSITIVE RESULTS FROM A CONFIRMATORY METHOD AND AN ALTERNATE METHOD. 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. THE PERFORMANCE OF THE ASSAY HAS NOT BEEN ESTABLISHED FOR POPULATIONS OF INFANTS OR CHILDREN. 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." SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. MDR 1219913-2022-00111 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2022-00110 ON 13-APR-2022. SIEMENS FILED THE MDR 1219913-2022-00110 SUPPLEMENTAL REPORT 1 ON 25-MAY-2022. 27-JUN-2022 ADDITIONAL INFORMATION: AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE POSITIVE RESULTS FROM A CONFIRMATORY METHOD AND AN ALTERNATE METHOD. THE CUSTOMER WAS ABLE TO PERFORM ADDITIONAL TESTING FOR THE PATIENT SAMPLE USING HETEROPHILES BLOCKING TUBES AND TESTED FOR BOTH THE CHIV AND EHIV ASSAYS. DUE TO THE LIMITED AMOUNT OF SAMPLE, BOTH CHIV AND EHIV WERE PERFORMED ON HETEROPHILE BLOCKING TREATED SAMPLE (NO EHIV ON PRETREATED SAMPLE). RESULTS (INDEX): (B)(6). . THE SIEMENS EHIV AND CHIV TESTS REACT TO P24 DIFFERENTLY. EHIV WILL PICK UP P24 ANTIBODY. CHIV PICKS UP P24 ANTIGEN. THE SIEMENS EHIV IS LIKELY PICKING UP P24 ANTIBODY IN THE SAMPLE. THE FACT THAT THE CUSTOMER OBSERVED WESTERN BLOT REACTIVE IS CONSISTENT WITH THIS BECAUSE WESTERN BLOT HIV TESTS USUALLY LOOK FOR ANTIBODIES AGAINST PROTEINS FROM THE CORE OF THE VIRUS: P17, P24, P55 AMONG OTHERS. THE ALTERNATE METHOD MAY BE PICKING UP SIMILARLY AND WAS THEREFORE REACTIVE. PER THE CUSTOMER THE BABY IS NOT POSITIVE FOR HIV WHICH IS CONSISTENT WITH CHIV NON-REACTIVE (P24 ANTIGEN NON-REACTIVE), SO THE BABY MAY ONLY HAVE ANTIBODIES FROM THE MOTHER, WHO IS HIV POSITIVE. 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. THE PERFORMANCE OF THE ASSAY HAS NOT BEEN ESTABLISHED FOR POPULATIONS OF INFANTS OR CHILDREN." NO POTENTIAL PRODUCT ISSUE IS OBSERVED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION CODES REAMINED THE SAME. MDR 1219913-2022-00111 SUPPLEMENTAL REPORT 2 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2022-00110 ON 13-APR-2022. 09-MAY-2022 ADDITIONAL INFORMATION: AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE POSITIVE RESULTS FROM A CONFIRMATORY METHOD AND AN ALTERNATE METHOD. SIEMENS REVIEWED THE AVAILABLE INFORMATION TO DETERMINE PROBABLE CAUSE AND EVALUATE FOR POTENTIAL PRODUCT ISSUE. QUALITY CONTROL (QC) WAS IN RANGE AT THE TIME THE SAMPLE WAS RUN. SAMPLE (B)(6) WAS THE ONLY AFFECTED SAMPLE INDICATING THIS IS A PATIENT/SAMPLE SPECIFIC OBSERVATION. PATIENT IS A 10-MONTH-OLD BABY OF AN HIV POSITIVE MOTHER. THERE IS NO INFORMATION WHETHER THE PATIENT IS UNDERGOING ANTI-RETROVIRAL THERAPY WHICH CAN CAUSE A NON-REACTIVE RESULT. THE SAMPLE WAS NOT ABLE TO BE RETURNED TO SIEMENS FOR FURTHER INVESTIGATION DUE TO CUSTOMER SITE LOCAL REGULATIONS. THE CAUSE OF THE NON-REACTIVE RESULT CANNOT BE DETERMINED. NO POTENTIAL PRODUCT ISSUE IS OBSERVED. THE SYSTEM IS OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS. MDR 1219913-2022-00111 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE POSITIVE RESULTS FROM A CONFIRMATORY METHOD AND AN ALTERNATE METHOD. THE CUSTOMER DID NOT REPORT THE NONREACTIVE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CHIV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708864 ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 310

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Male