BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 10636433 · Received October 6, 2020

    Report

    Report Number
    1219913-2020-00327
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 18, 2020
    Manufacturer
    FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO.
    Product Code
    QJR
    PMA / PMN Number
    EUA200571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED ON (B)(6) 2020 TO REPORT A FALSE-NEGATIVE FTD SARS-COV-2 RESULT. ADDITIONAL INFORMATION, (B)(6) 2020: THE CUSTOMER REPORTED A NEGATIVE RESULT FROM THE FTD SARS-COV-2 ASSAY, CONSIDERED DISCORDANT RELATIVE TO A POSITIVE RESULT FROM AN ALTERNATE METHOD. FOLLOWING THE DISCORDANT RESULT OBSERVATION, IT WAS NOTED THAT A CALIBRATION-PLATE TEST FAILED WHEN RUN ON THE ASSOCIATED AMPLIFICATION/DETECTION INSTRUMENT. THIS INSTRUMENT WAS ULTIMATELY REPLACED AS PART OF THE LOCAL TROUBLESHOOTING EFFORT AND SERVICE INTERVENTION. SIEMENS CONCLUDED THE INVESTIGATION ON (B)(6) 2020. A CAUSE FOR THE DISCORDANT NEGATIVE RESULT WAS NOT DEFINITIVELY IDENTIFIED. THERE HAVE BEEN NO ADDITIONAL REPORTS OF DISCORDANT SARS-COV-2 RESULTS FROM THIS CUSTOMER. BASED ON THE AVAILABLE INFORMATION, THE FTD SARS-COV-2 IS PERFORMING AS INTENDED AND A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED FTD (A SIEMENS HEALTHINEERS COMPANY) SARS-COV-2 RUN MET VALIDITY CRITERIA, INCLUDING NEGATIVE, AND POSITIVE CONTROL RESULTS. THE SAMPLE RESULT ALSO MET VALIDITY CRITERIA (VALID INTERNAL CONTROL), AND DEMONSTRATED NO TARGET AMPLIFICATION (NEGATIVE). IT IS NOT KNOWN WHETHER THE SAME SAMPLE ELUATE WAS USED FOR THE VIASURE TEST, OR IF AN ENTIRELY NEW EXTRACTION WAS PERFORMED. THE VIASURE RESULT (POSITIVE) WAS USED, RATHER THAN THE FTD (NEGATIVE) RESULT, DUE TO LOWER-THAN-EXPECTED SIGNAL IN THE FTD RUN. FTD TECHNICAL SUPPORT WAS INFORMED THAT THE CALIBRATION PLATE FAILED WHEN THE NEGATIVE RESULT FOR SARS-COV-2 PATHOGEN WAS OBSERVED. THE CUSTOMER HAS PERFORMED REPEAT TESTING BUT THE RESULTS HAVE NOT BEEN SHARED DUE TO A POTENTIAL PIPETTING ISSUE. PRODUCT DETAILS (CATALOG NUMBER, LOT NUMBER, UDI) WERE NOT AVAILABLE AT TIME OF FILING. THIS INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED IF IT BECOMES AVAILABLE. THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING : "OTHER PARAMETERS CAN LEAD TO FALSE POSITIVE, NEGATIVE, OR INVALID RESULTS RELATED TO PATIENT CONDITIONS (USE OF ANTIVIRAL THERAPY, PATIENT AGE, PATIENT HISTORY OF RESPIRATORY INFECTIONS, PRESENCE OF SYMPTOMS AND THE STAGE OF INFECTION)." "THIS TEST SHALL NOT BE THE ONLY ELEMENT CONSULTED FOR DIAGNOSIS OR TREATMENT DECISION. A SPECIMEN NOT DETECTED CANNOT BE PRESUMED TO BE NEGATIVE FOR THIS PATHOGEN SINCE RESULTS ARE DEPENDENT ON SEVERAL VARIABLES AS EXPLAINED ABOVE." SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NEGATIVE RESULT USING THE FTD SARS-COV-2 PCR TEST, WHICH WAS CONSIDERED DISCORDANT COMPARED TO A SUBSEQUENT RE-TEST USING AN ALTERNATE METHOD (VIASURE). THE DISCORDANT NEGATIVE RESULT FROM THE FTD ASSAY WAS NOT USED; THE VIASURE RESULT (POSITIVE) WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SARS-COV-2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098358 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID, PRODUCT CODE: QJR QJR FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1