BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 11325676 · Received February 12, 2021

    Report

    Report Number
    1219913-2021-00080
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 15, 2021
    Report Date
    February 12, 2021
    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
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC DETAILS REGARDING PATIENT INFORMATION OR SAMPLES TESTED WERE NOT PROVIDED. IT IS NOTED THAT ALL OF THE DISCORDANT RESULTS WERE REPRESENTED BY LATE CTS (>35) IN THE FTD SARS-COV-2 ASSAY, INDICATING LOW VIRAL CONCENTRATIONS. THE CONFIRMATORY METHOD USED BY THE CUSTOMER (EUROIMMUN) IS KNOWN TO BE SIGNIFICANTLY LESS SENSITIVE THAN THE FTD SARS-COV-2 TEST WHICH PRODUCED THE INITIAL POSITIVE RESULTS, SO SOME TRUE-POSITIVE SAMPLES WILL BE DETECTED BY THE FTD ASSAY WHICH WILL NOT BE DETECTED BY THE ALTERNATE METHOD. A CAUSE FOR THE DISCORDANCE BETWEEN THE OBSERVED RESULTS WAS NOT DEFINITIVELY IDENTIFIED, BUT IT IS LIKELY THAT THE PATIENTS IN QUESTION DEMONSTRATED VIRAL LOADS SUFFICIENT TO PRODUCE A POSITIVE RESULT BY THE FTD SARS-COV-2 ASSAY, WHILE FALLING BELOW THE LIMIT OF DETECTION (LOD) OF THE LESS-SENSITIVE CONFIRMATORY ASSAY. WHERE THE CUSTOMER ELECTED TO RE-TEST THE OBSERVED LOW-POSITIVE SAMPLES, A DELAY OCCURRED IN ASSOCIATION WITH THE (SAME-DAY) RE-TESTING. THE SLIGHT DELAY WAS APPARENT TO THE USER AND DID NOT IMPACT PATIENT CARE OR TREATMENT. 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. 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." 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

    THE CUSTOMER OBTAINED 10 POSITIVE FTD SARS-COV-2 RESULTS WHICH THEY CONSIDERED DISCORDANT RELATIVE TO TESTING BY AN ALTERNATE METHOD. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE RESULTS FROM THE FTD SARS-COV-2 ASSAY WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221098 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO. N/A SC20-96-51 05400829005906

    Patients

    Seq Age Sex Outcome Treatment
    1