BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11873251 · Received May 24, 2021

    Report

    Report Number
    1219913-2021-00326
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 3, 2021
    Report Date
    June 30, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    GEN2100036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2021-00326 ON MAY 24, 2021. (B)(6) 2021 ADDITIONAL INFORMATION: SIEMENS INVESTIGATED. A PATIENT RESULTED NONREACTIVE WITH ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG) LOT 001 AND REACTIVE WITH TWO ALTERNATE METHODS. THE PATIENT RECEIVED THE 2ND DOSE OF VACCINE ON (B)(6) 2021 AND THE SAMPLE WAS DRAWN ON (B)(6) 2021. TESTING AND/OR OTHER INFORMATION IS NOT AVAILABLE. IT IS CURRENTLY UNKNOWN HOW LONG SARS-COV-2 ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES CONFERS PROTECTIVE IMMUNITY. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH SARS-COV-2. PATIENT SPECIMENS MAY BE NONREACTIVE IF COLLECTED DURING THE EARLY (PRESEROCONVERSION) 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. 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. NO PRODUCT NON-CONFORMANCE IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 1

    THE QUALITY CONTROL (QC) RESULTS WERE WITHIN THE RANGE. THE PATIENT SAMPLE WAS PROCESSED IN DUPLICATE. THE SAME PATIENT SAMPLE WAS USED TO TEST ON THE TWO ALTERNATE METHODS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NONREACTIVE (NEGATIVE) ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WITH THE POSITIVE RESULTS FROM TWO ALTERNATE METHODS. THE PATIENT HAS BEEN VACCINATED AND RECEIVED BOTH DOSES. 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
    767296 ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR