BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG)

    MDR report key: 13118156 · Received December 30, 2021

    Report

    Report Number
    1219913-2021-00524
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    October 28, 2021
    Report Date
    April 20, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA202670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 AN OBSERVATION OF A POSITIVE (REACTIVE) ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) RESULT THAT WAS DISCORDANT TO ALTERNATE TEST METHODS. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATE: "RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. TEST RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, EPIDEMIOLOGICAL INFORMATION, AND OTHER LABORATORY FINDINGS." "IT IS CURRENTLY UNKNOWN HOW LONG SARS-COV-2 ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES CONFERS PROTECTIVE IMMUNITY." A FALSE POSITIVE/REACTIVE RESULT WOULD NOT BE USED IN ISOLATION AND WOULD BE CORRELATED WITH CLINICAL HISTORY. AT THIS TIME, THE PRESENCE OF AN IMMUNE RESPONSE CANNOT BE INTERPRETED AS CONFIRMATION OF IMMUNITY. THUS, CONTINUED PRECAUTIONS TO AVOID INFECTION WILL OCCUR WITH NEGLIGIBLE CLINICAL IMPACT. ALTHOUGH THERE IS NO POTENTIAL FOR SERIOUS INJURY IN THIS CASE, AN MDR WILL BE REPORTED TO THE FDA AS A REQUIREMENT OF THE EMERGENCY USE AUTHORIZATION (EUA). SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-000524 INITIAL REPORT ON 2021-12-30. ADDITIONAL INFORMATION - 2022-04-18. SIEMENS HAS CONCLUDED INVESTIGATION FOR A CUSTOMER OBSERVATION OF A POSITIVE (REACTIVE) ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) RESULT WITH LOT 012 THAT WAS DISCORDANT TO ALTERNATE METHODS. COMPLAINT LOT 012 HAS SINCE EXPIRED, THEREFORE FURTHER TESTING CANNOT BE PERFORMED. FOR THE ALLEGED FALSE POSITIVE ADVIA CENTAUR XPT SCOVG SAMPLE RESULT, DATA PROVIDED WAS INCONCLUSIVE TO WHETHER THE SAMPLE WAS REACTIVE ON SCOVG AS THE NUMERIC RESULT INDICATED A REACTIVE RESULT, BUT THE INTERPRETATION PROVIDED BY THE CUSTOMER WAS NEGATIVE. THE SAMPLE WAS NOT REPEATED ON THE SCOVG ASSAY. AS PER THE ADVIA CENTAUR XPT SCOVG IFU LIMITATIONS SECTION, "RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. TEST RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, EPIDEMIOLOGICAL INFORMATION, AND OTHER LABORATORY FINDINGS." SIEMENS'S INTERNAL DATA WAS REVIEWED FOR SCOVG LOT 012 AND ALL SPECIFICATIONS WERE BEING MET. NO PRODUCT NON CONFORMANCE HAS BEEN IDENTIFIED. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A POSITIVE (REACTIVE) ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) RESULT THAT WAS DISCORDANT TO ALTERNATE METHODS. THE CUSTOMER INDICATED THAT THE INITIAL RESULT WAS PROVIDED TO THE PHYSICIAN AND WERE QUESTIONED AND THAT A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE (REACTIVE) SCOVG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015685 ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown