BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HIV AG/AB COMBO (CHIV)

    MDR report key: 19740328 · Received July 15, 2024

    Report

    Report Number
    1219913-2024-00367
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 12, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A FALSE NEGATIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT. ASSAY CALIBRATION WAS VALID, AND NO ISSUES WERE OBSERVED WITH QUALITY CONTROL (QC) RESULTS. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." NOTE: SECTION G4 LISTS THE PMA/510(K)NUMBER OF SIMILAR US PRODUCT (SIEMENS MATERIAL NUMBER 10995459).

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A FALSE NEGATIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT. UPDATE, 12-AUG-2024: SIEMENS HAS CONCLUDED THE INVESTIGATION. REAGENT ISSUES WERE ESSENTIALLY RULED OUT AS QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES, AND NO OTHER SAMPLES WERE AFFECTED. NO INSTRUMENT PERFORMANCE ISSUES WERE IDENTIFIED. SIEMENS REQUESTED, BUT DID NOT RECEIVE, INFORMATION REGARDING WHETHER THE AFFECTED PATIENT WAS ON ANTI-RETROVIRAL THERAPY. THERE WAS NO ADDITIONAL SAMPLE MATERIAL AVAILABLE FOR ADDITIONAL TESTING. BASED ON THE AVAILABLE INFORMATION, NO FURTHER EVALUATION IS POSSIBLE. NO PRODUCT PROBLEM WAS IDENTIFIED; THE CUSTOMER IS OPERATIONAL. 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." "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." A PATIENT WHO HAS BEEN ON ANTI-RETROVIRAL THERAPY CAN PRODUCE NONREACTIVE ANTIBODY/ANTIGEN TEST RESULTS. THE IFU NOTES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS."

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF A FALSE NEGATIVE PATIENT RESULT WHEN USING ATELLICA IM HIV AG/AB COMBO (CHIV), LOT 353. THE CUSTOMER SERVES AS A REGIONAL REFERENCE LAB, AND RECEIVED A SAMPLE WHICH WAS INITIALLY POSITIVE FOR HIV AND HCV FOR CONFIRMATORY TESTING. WHEN TESTED USING ATELLICA IM CHIV, A NONREACTIVE RESULT WAS OBTAINED. THIS RESULT WAS NOT REPORTED. ADDITIONAL TESTING USING AN ALTERNATE TEST METHOD AND WESTERN BLOT PRODUCED POSITIVE RESULTS. REPEAT TESTING ON TWO IN-HOUSE ATELLICA IM ANALYZERS PRODUCED STRONGLY-REACTIVE RESULTS. THE SAMPLE WAS CONFIRMED TO BE HIV-REACTIVE. THE NONREACTIVE ATELLICA IM CHIV RESULT WAS IDENTIFIED AS DISCORDANT AND ERRONEOUS. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284963 ATELLICA IM HIV AG/AB COMBO (CHIV) TEST, HIV DETECTION MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown