BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM SARS-COV-2 TOTAL (COV2T)

    MDR report key: 11369480 · Received February 23, 2021

    Report

    Report Number
    1219913-2020-00153
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 27, 2021
    Report Date
    May 13, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA201367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS AT THE REQUEST OF FDA (RECEIVED MAY 12, 2021). SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2020-00153 INITIAL REPORT ON FEBRUARY 23, 2021 AND MDR 1219913-2020-00153 SUPPLEMENTAL 1 REPORT ON MAY 11, 2021 FOR AN EVENT THAT OCCURRED ON 01/27/2021. BECAUSE THE EVENT OCCURRED IN YEAR 2021, THE CFN-BASED REPORT NUMBER SHOULD HAVE BEEN FILED UNDER CFN-BASED REPORT NUMBER "1219913-2021-00153" INSTEAD OF "1219913-2020-00153". PER REQUEST OF THE FDA, THIS EVENT WAS REFILED ON MAY 13, 2021 UNDER THE CORRECT CFN-BASED REPORT NUMBER "1219913-2021-00153". THEREFORE, MDR 1219913-2020-00153 INITIAL REPORT PREVIOUSLY FILED ON FEBRUARY 23, 2021 AND MDR 1219913-2020-00153 SUPPLEMENTAL 1 REPORT PREVIOUSLY FILED ON MAY 11, 2021 SHOULD BE CONSIDERED DUPLICATE REPORTS.

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00153 INITIAL REPORT ON 02/23/2021. CORRECTION - THE CFN-BASED REPORT NUMBER PROVIDED WITHIN THE MDR INITIAL REPORT FILED ON 02/23/2021 WAS LISTED AS "1219913-2020-00153" INSTEAD OF THE CORRECT NUMBER "1219913-2021-00153". THE EXTERNAL FILENAME WAS CORRECT. BECAUSE OF THIS ERROR IN THE INITIAL MDR REPORT, TO ELECTRONICALLY FILE AND KEEP THIS MDR SUPPLEMENTAL 1 REPORT ALIGNED WITH THE MDR INITIAL REPORT, THE CFN-BASED REPORT NUMBER PROVIDED WITHIN THIS MDR SUPPLEMENTAL 1 REPORT WILL BE "1219913-2020-00153" AND THE EXTERNAL FILENAME WILL BE "1219913-2021-00153". FURTHER, SIEMENS CONFIRMS THAT IN YEAR 2020, NO MDR REPORT WAS FILED UNDER THE CFN-BASED REPORT NUMBER "1219913-2020-00153". ADDITIONAL INFORMATION - 04/16/2021, SIEMENS HEALTHCARE DIAGNOSTICS HAS 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 CUSTOMER HAS RECALIBRATED THE ASSAY AND USED FRESH REAGENT LOTS AND HAS VERIFIED THERE HAVE BEEN NO ISSUES WITH QUALITY CONTROL(QC). SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REPLACED THE ACID PUMP, CHECKED ASPIRATE DISPENSES, AND COMPLETED THE AUTO CHECKS. THE QC WAS RUN AND WAS ACCEPTABLE. 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 HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM SARS-COV-2 TOTAL (COV2T) RESULTS ON 4 PATIENT SAMPLES ON THE SAME DAY USING THE SAME INSTRUMENT. THE CUSTOMER BELIEVES THE REACTIVE RESULTS TO BE DISCORDANT COMPARED TO NONREACTIVE (NEGATIVE) COV2G RESULTS. THE REPEAT RESULT FOR 2 OF THE SAMPLES WAS REACTIVE (POSITIVE). THE REPEAT RESULTS FOR THE OTHER 2 SAMPLES WERE NONREACTIVE (NEGATIVE). ADDITIONAL TESTING WAS NOT PERFORMED ON THE SAMPLES. RESULTS WERE PROVIDED TO PHYSICIAN(S) AND WERE QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT REACTIVE (POSITIVE) COV2T RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263632 ATELLICA IM SARS-COV-2 TOTAL (COV2T) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 007

    Patients

    Seq Age Sex Outcome Treatment
    1