BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12046461 · Received June 22, 2021

    Report

    Report Number
    1219913-2021-00364
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 15, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA202670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE QUALITY CONTROL (QC) RESULTS WERE WITHIN THE RANGE. THE LIMITATIONS SECTION OF THE IFU STATES THE FOLLOWING: "PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR THE ASSAY USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC SARS-COV-2 SEROLOGICAL MARKERS. LABORATORIES ARE RESPONSIBLE FOR ESTABLISHING THEIR OWN PERFORMANCE CHARACTERISTICS. RESULTS OBTAINED WITH THE ASSAY MAY NOT BE USED INTERCHANGEABLY WITH VALUES OBTAINED WITH DIFFERENT MANUFACTURERS' TEST METHODS. A NEGATIVE RESULT FOR AN INDIVIDUAL SUBJECT INDICATES ABSENCE OF DETECTABLE ANTI-SARS-COV-2 ANTIBODIES. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. A NEGATIVE RESULT CAN OCCUR IF THE QUANTITY OF THE ANTI-SARS-COV-2 ANTIBODIES PRESENT IN THE SPECIMEN IS BELOW THE DETECTION LIMITS OF THE ASSAY, OR THE ANTIBODIES THAT ARE DETECTED ARE NOT PRESENT DURING THE STAGE OF DISEASE IN WHICH A SAMPLE IS COLLECTED. 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." A FALSE NEGATIVE/NON-REACTIVE RESULT WOULD BE CORRELATED WITH CLINICAL HISTORY AND PRESENTATION AND MAY LEAD TO ADDITIONAL TESTING AND/OR CONTINUED PRECAUTIONS TO AVOID INFECTION 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) AND/OR POLICY D. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2021-00364 ON JUNE 22, 2021. JUNE 30, 2021 ADDITIONAL INFORMATION: SIEMENS INVESTIGATED. THERE IS NOT AN EXPECTATION THE SIEMENS SCOVG ASSAY CORRELATES WITH ALL SEROLOGY METHODS DUE TO DIFFERENT ANTIGENS BEING USED, DIFFERENT SPECIFICITIES AND SENSITIVITIES OF THE SEROLOGY METHODS AND THE ASSAY ARCHITECTURE. THE SCOVG AND COV2T ASSAYS MAY NOT ALWAYS CORRELATE. THE SCOVG METHOD MEASURES IGG ANTIBODIES AND THE COV2T METHOD DETECTS IGG AND IGM ANTIBODIES. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH SARS-COV-2. IT IS CURRENTLY UNKNOWN HOW LONG SARS-COV-2 ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES CONFERS PROTECTIVE IMMUNITY. PATIENT SPECIMENS MAY BE NONREACTIVE IF COLLECTED DURING THE EARLY (PRE SEROCONVERSION) PHASE OF ILLNESS OR DUE TO A DECLINE IN TITER OVER TIME. IN ADDITION, THE IMMUNE RESPONSE MAY BE DEPRESSED IN ELDERLY, IMMUNOCOMPROMISED, OR IMMUNOSUPPRESSED PATIENTS. RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS. NO PRODUCT NON-CONFORMANCE IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2021-00364 ON JUNE 22, 2021. SIEMENS FILED MDR 1219913-2021-00364 SUPPLEMENTAL REPORT 1 ON JULY 12, 2021. JUNE 23, 2021 ADDITIONAL INFORMATION: THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER: -THE CUT-OFF FOR THE ALTERNATE METHOD IS = TO 0.8 U/ML FOR REACTIVE. JUNE 23, 2021 ADDITIONAL INFORMATION: THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER AND IS A CORRECTION TO SECTION B3 (DATE OF EVENT) OF THE INITIAL MDR: ALL THE TESTING FOR PATIENT 1 OCURRED ON 2021-05-07 ALL THE TESTING FOR PATIENT 2 OCURRED ON 2021-05-08.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2021-00364 ON JUNE 22, 2021. SIEMENS FILED MDR 1219913-2021-00364 SUPPLEMENTAL REPORT 1 ON JULY 12, 2021. SIEMENS FILED MDR 1219913-2021-00364 SUPPLEMENTAL REPORT 2 ON JULY 13, 2021. JUNE 17, 2021 CORRECTION: THIS A CORRECTION TO (PMA/510(K)) OF THE INITIAL MDR. THE INITIAL MDR WAS FILED UNDER THE POLICY D NUMBER (B)(4). THE CORRECT NUMBER IS EUA NUMBER (B)(4). WAS UPDATED WITH THE INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG) RESULTS FOR SAMPLES FROM TWO PATIENTS AND WERE CONSIDERED DISCORDANT WITH THE REACTIVE (POSITIVE) RESULTS FROM AN ALTERNATE METHOD AND THE ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SCOVG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939977 ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 006

    Patients

    Seq Age Sex Outcome Treatment
    1