BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T)

    MDR report key: 10733144 · Received October 26, 2020

    Report

    Report Number
    1219913-2020-00388
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 11, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA201370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED INITIAL MDR 1219913-2020-00388 ON OCTOBER 26, 2020. CORRECTION 11/16/2020: INITIAL MDR 1219913-2020-00388 INDICATED THAT THE CUSTOMER REPORTED THE NONREACTIVE (NEGATIVE) RESULTS TO PHYSICIAN. NEW INFORMATION FROM 11/16/2020 STATES THAT INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. ADDITIONAL INFORMATION 11/16/2020: THE DEVICE WAS NOT SERVICED BY A THIRD PARTY. CUSTOMER NAME AND TELEPHONE NUMBER WAS PROVIDED. ADDITIONAL INFORMATION - 11/30/2020: SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED ITS INVESTIGATION OF ATELLICA IM AND ADVIA CENTAUR SARS-COV-2 TOTAL (COV2T) NON-REPRODUCIBLE FALSE REACTIVE RESULTS WITH KIT LOTS ENDING IN 004, 005, 035 AND 006. SIEMENS INVESTIGATION DETERMINED THAT ALTHOUGH NON-REPRODUCIBLE FALSE REACTIVE RESULTS WERE OBSERVED WITH MULTIPLE KIT LOTS, RESULTS INDICATE THE NEGATIVE PERCENT AGREEMENT CONFIDENCE INTERVAL OF THE KIT LOTS EVALUATED OVERLAP THE CONFIDENCE INTERVAL IN THE IFU; THEREFORE THEY ARE PERFORMING WITHIN CLAIMS AND A CHANGE IN PERFORMANCE HAS NOT BEEN CONFIRMED. THE IFU STATES IN THE LIMITATIONS SECTION: "THIS ASSAY SHOULD NOT BE USED TO DIAGNOSE OR EXCLUDE ACUTE INFECTION. 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 REACTIVE TEST RESULT DOES NOT EXCLUDE PAST OR PRESENT INFECTION BY OTHER CORONAVIRUSES, SUCH AS SARS COV-1, MERS-COV, HKU1, 229E, NL63, OR OC43." A FALSE POSITIVE/REACTIVE RESULT WOULD NOT BE USED IN ISOLATION AND WOULD BE CORRELATED WITH CLINICAL HISTORY. ADDITIONAL LABORATORY TESTING WOULD BE USED TO DETERMINE SPECIFIC ANTIBODY PRESENCE. THE ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) LOT 005 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QUALITY CONTROL (QC) RESULTS WERE VALID. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "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 REACTIVE TEST RESULT DOES NOT EXCLUDE PAST OR PRESENT INFECTION BY OTHER CORONAVIRUSES, SUCH AS SARS-COV-1, MERS-COV, HKU1, 229E, NL63, OR OC43, OR DUE TO CROSS-REACTIVITY FROM PRE-EXISTING ANTIBODIES OR OTHER POSSIBLE CAUSES." A FALSE POSITIVE/REACTIVE RESULT WOULD NOT BE USED IN ISOLATION AND WOULD BE CORRELATED WITH CLINICAL HISTORY. ADDITIONAL LABORATORY TESTING WOULD BE USED TO DETERMINE SPECIFIC ANTIBODY PRESENCE. 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 · 1

    THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) RESULTS FOR THREE PATIENTS. THE INITIAL REACTIVE (POSITIVE) RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE NONREACTIVE (NEGATIVE) REPEAT RESULTS. THE REPEAT TESTING WAS PERFORMED USING THE SAME SAMPLES. THE CUSTOMER REPORTED THE NONREACTIVE (NEGATIVE) RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT COV2T RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197669 ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 005

    Patients

    Seq Age Sex Outcome Treatment
    1