BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY

    MDR report key: 12980956 · Received December 10, 2021

    Report

    Report Number
    1219913-2021-00505
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    December 3, 2021
    Report Date
    February 16, 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 1219913-2021-00505 ON 2021-12-10. ADDITIONAL INFORMATION, 2022-02-08: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE CUSTOMER REPORTED OBSERVATION OF FALSELY-NEGATIVE (NONREACTIVE) ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) RESULTS. THE NONREACTIVE RESULTS WERE DISCORDANT RELATIVE TO RESULTS PRODUCED USING AN ALTERNATE SAMPLE TYPE AND AN ALTERNATE TESTING METHOD. THE CUSTOMER OBSERVED CHIV RESULTS WHICH DIFFERED BETWEEN SAMPLES TYPES (SERUM VS EDTA PLASMA) AND TEST METHODS. SIEMENS REVIEWED THE AVAILABLE INFORMATION TO DETERMINE PROBABLE CAUSE AND EVALUATE FOR POTENTIAL PRODUCT ISSUES. ACCORDING TO THE ASSAY'S INSTRUCTIONS FOR USE (IFU), THESE TWO SAMPLE TYPES SHOULD PRODUCE COMPARABLE RESULTS. THE CUSTOMER'S QUALITY CONTROL (QC) RESULTS WERE IN RANGE, INDICATING THAT THIS MAY BE A SAMPLE-SPECIFIC ISSUE. THERE IS NO ADDITIONAL SAMPLE AVAILABLE FROM THE AFFECTED PATIENTS TO SENT TO SIEMENS FOR ANY FURTHER INVESTIGATION. SIEMENS EXPRESSES NO CLAIM REGARDING RESULT AGREEMENT WITH ALTERNATE METHODS. REGARDING THE OBSERVED DISAGREEMENT BETWEEN SAMPLE TYPES WHEN TESTED USING ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV), IT WAS NOTED THAT THE CUSTOMER IS NOT ADHERING TO THE TESTING ALGORITHM PRESCRIBED IN THE IFU: IF SAMPLES ARE INITIALLY ELEVATED, RE-CENTRIFUGE 10000G/10 MIN, REPEAT TESTING IN DUPLICATE, AND IF STILL POSITIVE SEND FOR SUPPLEMENTAL TESTING. SIEMENS CANNOT RULE OUT SAMPLE HANDLING AS THE CAUSE OF THE OBSERVED DISCORDANCE BETWEEN EDTA AND SERUM RESULTS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR CHIV. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER INVESTIGATION IS REQUIRED. NOTES: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED ON THE BASIS OF THE INVESTIGATION RESULTS. MDR 1219913-2021-00506 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED DISCORDANT NONREACTIVE ((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: "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 (B)(6) MAY NOT DETECT ALL INFECTED INDIVIDUALS. A (B)(6) DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) 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." MDR 1219913-2021-00506 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF (B)(6) (NONREACTIVE) ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) RESULTS FOR 3 PATIENTS. THE NONREACTIVE RESULTS WERE OBTAINED USING PLASMA (EDTA) AND ARE CONSIDERED DISCORDANT WITH THE POSITIVE (REACTIVE) RESULTS OBTAINED USING SST ON ADVIA CENTAUR CP AND ROCHE AND EDTA ON ROCHE. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877029 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 Unknown