BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM SARS-COV-2 TOTAL (COV2T)

    MDR report key: 10770946 · Received November 2, 2020

    Report

    Report Number
    1219913-2020-00476
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 6, 2020
    Report Date
    December 18, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA201367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2020-00476 ON NOVEMBER 02, 2020. NOVEMBER 6, 2020 ADDITIONAL INFORMATION: THE ANSWER TO THE QUESTION "WAS THIS DEVICE SERVICED BY A THIRD PARTY?" WAS RECEIVED AS "NO". THE SAMPLE TYPE WAS SERUM.. THE REACTIVE (POSITIVE) ATELLICA IM SARS-COV-2 TOTAL (COV2T) RESULTS WERE NOT REPORTED. THE CUSTOMER ONLY REPORTED RESULTS AFTER RERUNS. THE RATE OF NON-REPRODUCIBLE SAMPLES WAS PROVIDED BY THE CUSTOMER FOR THREE OF THE DAYS: 2020-10-01 34 SAMPLES TESTED, 3 SAMPLES WERE NON-REPRODUCIBLE. 2020-10-03 45 SAMPLES TESTED, 1 SAMPLE WAS NON-REPRODUCIBLE. 2020-10-05 49 SAMPLES TESTED, 4 SAMPLES WERE NON-REPRODUCIBLE. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2020-00476 ON NOVEMBER 02, 2020. SIEMENS FILED THE MDR 1219913-2020-00476 SUPPLEMENTAL REPORT 1 ON DECEMBER 01, 2020. NOVEMBER 24, 2020 ADDITIONAL INFORMATION: 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 ATELLICA IM 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.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM SARS-COV-2 TOTAL (COV2T) RESULTS FOR A NUMBER OF PATIENTS. THE INITIAL REACTIVE (POSITIVE) RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE NONREACTIVE (NEGATIVE) REPEAT 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
    1235364 ATELLICA IM SARS-COV-2 TOTAL (COV2T) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 005

    Patients

    Seq Age Sex Outcome Treatment
    1