BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR SARS-COV-2 TOTAL (COV2T)

    MDR report key: 10537803 · Received September 15, 2020

    Report

    Report Number
    1219913-2020-00248
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Report Date
    December 8, 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 · 0

    MDR 1219913-2020-00248 WAS FILED ON SEPTEMBER 15, 2020 REPORTING SEVERAL INITIALLY REACTIVE (POSITIVE) ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) RESULTS THAT WERE NONREACTIVE(NEGATIVE) UPON REPEAT TESTING AND ON AN ALTERNATE METHOD. ADDITIONAL INFORMATION SEPTEMBER 18, 2020 THROUGH OCTOBER 7, 2020: THE CUSTOMER CONTINUED TO NOTIFY SIEMENS OF ADDITIONAL SAMPLES THAT WERE INITIALLY REACTIVE THAT WERE NON-REACTIVE UPON REPEAT TESTING AS THEY CONTINUED TO MONITOR PERFORMANCE OF THE ASSAY. THE ATTACHED SPREADSHEET, 'RESULTS FOR MDRS 1219913-2020-243 THROUGH 248 AND 395 THROUGH 401 406 AND 407.PDF' CONTAINS A LIST OF THE SAMPLES INCLUDING THE SAMPLES THAT WERE INITIALLY FILED IN MDRS 1219913-2020-00243, 1219913-2020-00244, 1219913-2020-00245, 1219913-2020-00246, 1219913-2020-00247 AND 1219913-2020-00248. SIEMENS CONTINUES TO INVESTIGATE. MDRS 1219913-2020-00243 SUPPLEMENTAL 1, 1219913-2020-00244 SUPPLEMENTAL 1, 1219913-2020-00245 SUPPLEMENTAL 1, 1219913-2020-00246 SUPPLEMENTAL 1 AND 1219913-2020-00247 SUPPLEMENTAL 1 WERE FILED FOR DIFFERENT TESTING DATES.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2020-00248, WAS FILED ON (B)(6) 2020, REPORTING SEVERAL INITIALLY REACTIVE (POSITIVE) ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) RESULTS THAT WERE NONREACTIVE(NEGATIVE) UPON REPEAT TESTING AND ON AN ALTERNATE METHOD. MDR 1219913-2020-00248, SUPPLEMENTAL 1 WAS FILED ON (B)(6) 2020, WITH ADDITIONAL INFORMATION ADDITIONAL INFORMATION (B)(6) 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 AND 035 ARE PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED. MDRS 1219913-2020-00243, SUPPLEMENTAL 2 THROUGH 1219913-2020-00248, SUPPLEMENTAL 2 WERE FILED FOR DIFFERENT TESTING DATES. MDRS 1219913-2020-00395, SUPPLEMENTAL 1 THROUGH 1219913-2020-00401, SUPPLEMENTAL 1 AND 1219913-2020-00406, SUPPLEMENTAL 1 AND 1219913-2020-00407, SUPPLEMENTAL 1 WERE FILED FOR DIFFERENT TEST DATES AND DIFFERENT LOT NUMBERS.

    Additional Manufacturer Narrative · 1

    SIEMENS WENT ONSITE AND REVIEWED THE BACKGROUND COUNTS AND DETERMINED THAT THEY WERE REASONABLE. WHILE ON-SITE, IT WAS DETERMINED THAT MONTHLY MAINTENANCE HAD NOT BEEN PERFORMED SINCE JULY 30, 2020. SIEMENS INFORMED THE CUSTOMER THAT THE SYSTEM MUST BE MAINTAINED AND KEPT UPDATED. SIEMENS CONTINUES TO INVESTIGATE. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "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. 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). MDRS 1219913-2020-00243, 1219913-2020-00244, 1219913-2020-00245, 1219913-2020-00246 AND 1219913-2020-00247 WERE FILED FOR DIFFERENT TESTING DATES.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SEVERAL INITIALLY REACTIVE (POSITIVE) ADVIA CENTAUR XP SARS-COV-2 TOTAL (COV2T) RESULTS THAT WERE NON-REACTIVE (NEGATIVE) UPON REPEAT TESTING AND ON AN ALTERNATE METHOD. THE REACTIVE RESULTS WERE NOT REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT COV2T RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999989 ADVIA CENTAUR SARS-COV-2 TOTAL (COV2T) SARS-COV-2 IMMUNOASSAY,, QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 005

    Patients

    Seq Age Sex Outcome Treatment
    1