BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 12085732 · Received June 29, 2021

    Report

    Report Number
    1219913-2021-00365
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 9, 2021
    Report Date
    June 29, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QJR
    UDI-DI
    05400829005883
    PMA / PMN Number
    EUA200571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED OBSERVATION OF FALSE-POSITIVE FTD SARS-COV-2 ASSAY RESULTS, WHERE EVERY WELL OF AN ASSAY PLATE DEMONSTRATED SARS-COV-2 TARGET AMPLIFICATION ((B)(6) 2021). RE-TESTING OF THE SAME SAMPLES USING ANOTHER ASSAY KIT FROM THE SAME PRODUCTION LOT WAS REPORTED TO PRODUCE SATISFACTORY RESULTS; DETAILS/DATA WERE NOT PROVIDED. PRESUMABLY, THE OBSERVED SPURIOUS AMPLIFICATION ALSO AFFECTED THE ASSAY NEGATIVE CONTROL, RENDERING THE ASSAY RUN INVALID - BUT SIEMENS HAS BEEN UNABLE TO REVIEW THE CUSTOMER'S DATA AND CONFIRM DETAILS OF THE OBSERVATION. THE PRESUMPTIVE CAUSE OF THE OBSERVED FALSE-POSITIVE RESPONSE IS CONTAMINATION, BUT THE SPECIFIC SOURCE CANNOT BE IDENTIFIED. SUCCESS OF THE FOLLOWING ASSAY RUN INDICATES THAT THERE IS NO LOT-SPECIFIC PROBLEM, AND NO RESIDUAL CONTAMINATION ISSUE AT THE SITE. THE OBSERVED FALSE-POSITIVE RESULTS ARE MOST LIKELY THE RESULT OF USER CROSS-CONTAMINATION OF EQUIPMENT AND/OR REAGENTS; IF RESULTS WERE REPORTED FROM AN INVALID RUN, THIS REPRESENTS A USE ERROR WITH RESPECT TO ASSAY-VALIDITY CRITERIA. NO PRODUCT MALFUNCTION WAS IDENTIFIED. NO FURTHER EVALUATION OF THE PRODUCT IS REQUIRED. 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 OBSERVED FALSE-POSITIVE FTD SARS-COV-2 RESULTS WHICH WERE DISCORDANT RELATIVE TO SUBSEQUENT RE-TEST. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FTD SARS-COV-2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979935 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A SC20-32-07 05400829005883

    Patients

    Seq Age Sex Outcome Treatment
    1