BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM SARS-COV-2 TOTAL (COV2T)

    MDR report key: 10185226 · Received June 23, 2020

    Report

    Report Number
    1219913-2020-00148
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    June 5, 2020
    Report Date
    July 24, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QKO
    PMA / PMN Number
    EUA201367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2020-00148 ON (B)(6) 2020. (B)(6) 2020 CORRECTION: IN THE INITIAL MDR REPORT SECTION D2, THE INCORRECT PRODUCT CODE WAS DOCUMENTED. THE CORRECT PRODUCT CODE IS QKO. SECTION D2 HAS BEEN UPDATED WITH THIS INFORMATION. IN THE INITIAL MDR REPORT SECTION H4, THE DEVICE MANUFACTURE DATE WAS INADVERTENTLY OMITTED. THE DEVICE MANUFACTURE DATE IS (B)(6) 2020. SECTION H4 HAS BEEN UPDATED WITH THIS INFORMATION. (B)(6) 2020, ADDITIONAL INFORMATION: SIEMENS HAS INVESTIGATED THIS INCIDENT. THE PATIENT SAMPLE IS NO LONGER AVAILABLE FOR FURTHER TESTING AND INVESTIGATION AND PATIENT SYMPTOMOLOGY IS NOT AVAILABLE, THEREFORE, SIEMENS IS UNABLE TO DETERMINE THE ROOT CAUSE. THE ATELLICA IM COV2T IFU (11206906_EN REV. (B)(6) 2020) STATES POSITIVE AGREEMENT IS 100% WITH A 95% CONFIDENCE INTERVAL OF 91.59-100.0%. SIEMENS IS UNABLE TO RULE OUT A SAMPLE SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT PROBLEM IS IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SECTION H6, THE DEVICE, METHOD, RESULTS AND CONCLUSION CODES WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. MDR 1219913-2020-00147 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME PATIENT SAMPLE ON A DIFFERENT TEST DATE.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION WAS ACCEPTABLE AND THE QUALITY CONTROL (QC) WAS WITHIN RANGE. THE CUSTOMER STATED THAT THEY BATCH THEIR COVID SAMPLE TEST AND THE ATELLICA IM IS CLEANED BEFORE AND AFTER THE RUNS, PER INSTRUCTIONS FOR USE (IFU). THE CUSTOMER STATED THAT A FEW OTHER COVID SAMPLES WERE RUN ALONG WITH THIS PATIENT SAMPLE AND NO OTHER PATIENT SAMPLE RESULTS ARE BEING QUESTIONED. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE LIMITATIONS SECTION: "PATIENT SPECIMENS MAY BE NONREACTIVE IF COLLECTED DURING THE EARLY (PRE-SEROCONVERSION) PHASE OF ILLNESS OR DUE TO A DECLINE IN TITER OVER TIME. IN ADDITION, THE IMMUNE RESPONSE MAY BE DEPRESSED IN ELDERLY, IMMUNOCOMPROMISED, OR IMMUNOSUPPRESSED PATIENTS." A FALSE NEGATIVE/NON-REACTIVE RESULT WOULD BE CORRELATED WITH CLINICAL HISTORY AND PRESENTATION AND MAY LEAD TO ADDITIONAL TESTING AND/OR CONTINUED PRECAUTIONS TO AVOID INFECTION WITH NEGLIGIBLE CLINICAL IMPACT. 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). MDR 1219913-2020-00147 WAS FILED FOR THE SAME PATIENT SAMPLE ON A DIFFERENT TEST DATE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A DISCORDANT NONREACTIVE (NEGATIVE) ATELLICA IM SARS-COV-2 TOTAL (COV2T) RESULT FOR A PATIENT SAMPLE ON (B)(6) 2020. THE SAMPLE WAS REPEATED ON THE ATELLICA IM SARS-COV-2 TOTAL (COV2T) ASSAY ON (B)(6) 2020 AND THE RESULT WAS AGAIN NONREACTIVE. THE PATIENT SAMPLE WAS INITIALLY TESTED ON (B)(6) 2020 USING THE PCR METHOD AT (B)(6) AND THE RESULT WAS POSITIVE. THE PATIENT SAMPLE WAS RETESTED AT (B)(6) USING THE PCR METHOD ON (B)(6) 2020 AND A NEGATIVE RESULT WAS OBTAINED. THE INITIAL ATELLICA IM RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NONREACTIVE COV2T RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646680 ATELLICA IM SARS-COV-2 TOTAL (COV2T) SARS-COV-2 IMMUNOASSAY QKO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 001

    Patients

    Seq Age Sex Outcome Treatment
    1