BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM SARS-COV-2 TOTAL (COV2T)

    MDR report key: 11816196 · Received May 13, 2021

    Report

    Report Number
    1219913-2021-00253
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 19, 2021
    Report Date
    July 23, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA201367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00253 INITIAL REPORT ON MAY 12, 2021. ADDITIONAL INFORMATION - 2021-06-28, THE DATE OF THIS EVENT WAS NOT PROVIDED IN MDR 1219913-2021-00253 INITIAL REPORT BECAUSE THE CUSTOMER DID NOT PROVIDE THE DATE THAT THE DISCORDANT RESULTS WERE OBTAINED. THE DATE OF (B)(6) 2021 HAS BEEN ADDED TO SECTION B3 OF THIS REPORT AS THE DATE OF EVENT, EVEN THOUGH IT IS BEYOND THE EXPIRATION DATE OF LOT 007 (2021-03-10), BECAUSE OF THE FOLLOWING CLARIFICATION FROM THE CUSTOMER: THE CUSTOMER OBSERVED FEWER FALSE REACTIVE RESULTS WHEN THEY BEGAN USING ATELLICA IM SARS-COV-2 TOTAL (COV2T) LOT 010 FOR TESTING COMPARED TO THE FALSE REACTIVE RATE OBSERVED WITH LOT 007 (COMPLAINT LOT). THE CUSTOMER PERFORMED A COMPARISON STUDY AS DESCRIBED IN SECTION H10 OF MDR 1219913-2021-00253 INITIAL REPORT. ON (B)(6) 2021, THE CUSTOMER COMPARISON STUDY RESULTS INDICATED AN INCREASED RATE OF FALSE POSITIVE RESULTS WHEN USING LOT 007 COMPARED TO LOT 010 AND CONSEQUENTLY INFORMED SIEMENS OF THE POTENTIAL PROBLEM. ADDITIONAL INFORMATION 2021-07-01 SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED ITS INVESTIGATION OF ATELLICA IM AND ADVIA CENTAUR SARS-COV-2 TOTAL (COV2T) LOT 007 NON-REPRODUCIBLE FALSE REACTIVE (POSITIVE) RESULTS. RESULTS OF THE INVESTIGATION INDICATE THAT ALTHOUGH NON-REPRODUCIBLE FALSE REACTIVE (POSITIVE) RESULTS WERE OBSERVED, THE NEGATIVE PERCENT AGREEMENT CONFIDENCE INTERVAL OF THE KIT LOTS EVALUATED OVERLAP THE CONFIDENCE INTERVAL LISTED IN THE ASSAY INSTRUCTIONS FOR USE (IFU); THEREFORE, THE PRODUCT IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE PROBLEM HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION WAS ACCEPTABLE, AND THE QUALITY CONTROL (QC) WAS WITHIN RANGE. THE CUSTOMER PERFORMED AN EXPERIMENT WHERE 740 SERUM SAMPLES WERE TESTED; 33 WERE REACTIVE (POSITIVE) BUT UPON REPEAT, THEY WERE NON-REACTIVE (NEGATIVE). THE RATIO OF FALSE POSITIVE RESULTS WAS 4.46% FOR LOT 007. IN ADDITION, 199 PLASMA SAMPLES WERE TESTED AND ALL RESULTS WERE NON-REACTIVE (NEGATIVE). THE CUSTOMER NOTED THAT THE LOT 007 INDEX MEDIAN WAS HIGH COMPARED TO THE INDEX MEDIAN OF LOT 010, WITH NO FALSE POSITIVE RESULTS OBSERVED. THE CUSTOMER HAS SWITCHED TO LOT 010. 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 RESULT WOULD HAVE NEGLIGIBLE CLINICAL IMPACT AS MANAGEMENT AND TREATMENT DECISIONS ARE BASED ON SEVERITY OF CLINICAL PRESENTATION AND MANAGEMENT PRIMARILY CONSISTS OF SUPPORTIVE CARE. 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 IS INVESTIGATING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM SARS-COV-2 TOTAL (COV2T) RESULTS FOR MULTIPLE PATIENTS. THE INITIAL REACTIVE (POSITIVE) RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE NONREACTIVE (NEGATIVE) REPEAT RESULTS. PATIENT RESULTS WERE NOT REPORTED TO PHYSICIAN, AS THIS CUSTOMER IS A RESEARCH LABORATORY. 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
    718512 ATELLICA IM SARS-COV-2 TOTAL (COV2T) SARS-COV-2 TOTAL IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 007

    Patients

    Seq Age Sex Outcome Treatment
    1