BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 11046359 · Received December 21, 2020

    Report

    Report Number
    1219913-2020-00652
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 18, 2020
    Manufacturer
    FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO.
    Product Code
    QJR
    UDI-DI
    05400829005906
    PMA / PMN Number
    EUA200571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS REVIEWED THE CUSTOMER DATA FOM THE FTD (A SIEMENS HEALTHINEERS COMPANY) SARS-COV-2 RUNS IN QUESTION. THE FOLLOWING WERE NOTED: THE INITIAL POSITIVE RESULT DEMONSTRATED LATE AMPLIFICATION (CT ~37), REGISTERING SIGNAL AT THE ASSAY'S LIMIT OF DETECTION (LOD). THE SECOND (NEGATIVE) RESULT DID NOT SHOW AMPLIFICATION. THE OBSERVED DIFFERENCE IN RESULTS IS CONSISTENT WITH THE PERFORMANCE EXPECTATIONS FOR THE ASSAY AT ITS LOD. THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN THE LIMITATIONS SECTION: "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." 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. 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).

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED ONE SAMPLE FOR WHICH AN INITIAL POSITIVE FTD SARS-COV-2 RESULT CONFLICTED WITH A NEGATIVE RESULT FROM A LATER RE-TEST OF THE SAME SAMPLE, USING THE SAME METHOD. THE RESULTS FROM THE FTD SARS-COV-2 ASSAY WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, DELAY IN TREATMENT, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514368 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID, PRODUCT CODE: QJR QJR FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO. N/A SC20-96-42 05400829005906

    Patients

    Seq Age Sex Outcome Treatment
    1