BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR SARS-COV-2 IGG (SCOVG)

    MDR report key: 15878390 · Received November 29, 2022

    Report

    Report Number
    1219913-2022-00404
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 22, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA202670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE OF THE UNITED STATES OBSERVED REPRODUCIBLE CALIBRATION FAILURE WHEN USING THE ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) ASSAY. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DIAGNOSTIC DELAYS DUE TO THE OBSERVED CALIBRATION FAILURE. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE OBSERVED PROBLEM. 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).

    Additional Manufacturer Narrative · 0

    MDR 1219913-2022-00404 WAS INITIALLY FILED ON 2022-11-29. ADDITIONAL INFORMATION, 2022-12-13: SIEMENS HEALTHCARE DIAGNOSTICS INC. INVESTIGATION CONFIRMED THAT THE FAILED CALIBRATIONS ARE DUE TO THE STANDARD S01 VALUE IN THE MASTER CURVE CARD (MCC) FOR THE ADVIA CENTAUR SYSTEMS LOTS 19529015 AND 27236015, BEING SET AT 0.1 INDEX. THE S01 VALUE SHOULD BE 0.01 INDEX. THE ISSUE IS ISOLATED TO THE ADVIA CENTAUR SYSTEMS SCOVG LOTS 19529015 AND 27236015, SMNS 1120376 AND 1120379. CUSTOMERS WERE NOTIFIED OF THE ISSUE AND INSTRUCTED TO DISCONTINUE USE OF THE KITS. (US: CC 23-01.A.US WAS SENT TO US CUSTOMERS ON 2022-12-16 AND OUTSIDE THE US: CC 23-01.A.OUS WAS SENT TO CUSTOMERS ON 2022-12-16 WHO HAVE RECEIVED THE ADVIA CENTAUR SYSTEMS SARS-COV-2 IGG (SCOVG) LOTS 19529015 AND 27236015). NOTE: IN SECTION H6, THE CODES FOR TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLE CALIBRATION FAILURE WHEN USING THE ADVIA CENTAUR SARS-COV-2 IGG (SCOVG) ASSAY. HIGH CV FOR THE HIGH CALIBRATOR WAS OBSERVED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SCOVG CALIBRATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947552 ADVIA CENTAUR SARS-COV-2 IGG (SCOVG) SARS-COV-2 IMMUNOASSAY, QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown