BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15797941 · Received November 15, 2022

    Report

    Report Number
    1219913-2022-00399
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 21, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA202670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE OF THE UNITED STATES OBSERVED CALIBRATION FAILURE DUE TO LOW CALIBRATOR DEVIATION 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

    SIEMENS FILED THE INITIAL MDR 1219913-2022-00399 ON NOVEMBER 15, 2022. DECEMBER 13, 2022 ADDITIONAL INFORMATION: 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). IN SECTION H6, THE TYPE OF INVESTIGATION, INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF CALIBRATION FAILURE DUE TO LOW CALIBRATOR DEVIATION WHEN USING ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) ASSAY. 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
    1120685 ADVIA CENTAUR SARS-COV-2 IGG (SCOVG) ASSAY SARS-COV-2 IGG (SCOVG) ASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown