BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 11333925 · Received February 16, 2021

    Report

    Report Number
    1219913-2021-00103
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 19, 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

    IT IS NOTED THAT ALL OF THE DISCORDANT RESULTS WERE REPRESENTED BY LATE CTS (>36) IN THE FTD SARS-COV-2 ASSAY, INDICATING VERY LOW VIRAL CONCENTRATIONS. OBSERVATIONS NEAR THE ASSAY'S LIMIT OF DETECTION (LOD) MAY NOT BE REPRODUCIBLY POSITIVE. 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. 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). SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    MDR 1219913-2021-00103 WAS FILED ON 16-FEB-2021 TO REPORT 10 DISCORDANT POSITIVE FTD SARS-COV-2 RESULTS. ADDITIONAL INFORMATION RECEIVED 24-FEB-2021 AND 04-MAR-2021: CONTAMINATION (OF REAGENTS OR INSTRUMENT) WAS SUSPECTED AS A POTENTIAL CAUSE FOR THE DISCORDANT POSITIVE OBSERVATIONS, AND CUSTOMER WORKFLOW WAS EXAMINED. IT WAS DETERMINED THAT THE CUSTOMER IS NOT USING THE RECOMMENDED AUTOMATED PROTOCOL FOR SAMPLE AND ASSAY PREPARATION. ADDITIONAL INVESTIGATION FURTHER REVEALED THAT THE CUSTOMER HAS NOT BEEN TESTING AND EVALUATING THE NEGATIVE CONTROL FOR ASSAY VALIDATION. AS A RESULT, THE AFFECTED ASSAY RUNS WERE NOT ASSESSED FOR SPURIOUS TARGET SIGNAL, AND REAGENT CONTAMINATION CANNOT BE RULED OUT AS A ROOT CAUSE OF THE FALSE-POSITIVE RESULTS. WITHOUT EVALUATION OF A NEGATIVE CONTROL, THE RUNS AND RESULTS IN QUESTION SHOULD HAVE BEEN CONSIDERED INVALID ACCORDING TO THE STATED CRITERIA FOR A VALID RUN IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU). A POTENTIAL PRODUCT ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED 10 POSITIVE FTD SARS-COV-2 RESULTS USING KIT LOT SC20-96-51 WHICH THEY CONSIDERED DISCORDANT RELATIVE TO RE-TESTING USING KIT LOT SC20-96-50. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] WHERE DISCORDANCE WAS OBSERVED, THE NEGATIVE RESULTS WERE REPORTED AS CORRECT BY THE CUSTOMER. 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
    231899 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