BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15876359 · Received November 29, 2022

    Report

    Report Number
    1219913-2022-00416
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 22, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    QKO
    PMA / PMN Number
    EUA202670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2022-00416 ON NOV 29, 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 (B)(6) 2022 AND OUTSIDE THE US: CC 23-01.A.OUS WAS SENT TO CUSTOMERS ON (B)(6) 2022 WHO HAVE RECEIVED THE ADVIA CENTAUR SYSTEMS SARS-COV-2 IGG (SCOVG) LOTS 19529015 AND 27236015). IN SECTION H6, MEDICAL DEVICE PROBLEM CODE, THE TYPE OF INVESTIGATION, INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTS OBSERVATION OF CALIBRATION FAILURE DUE TO LOW CALIBRATOR DEVIATION WHEN USING ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG), LOT 015. 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 HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    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), LOT 015. 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
    1947432 ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS N/A 015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown