BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 11059231 · Received December 22, 2020

    Report

    Report Number
    1219913-2020-00651
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 22, 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

    DATA FROM THE AFFECTED FTD (A SIEMENS HEALTHINESS COMPANY) SARS-COV-2 RUNS WERE NOT PROVIDED. SIEMENS DOES NOT HAVE SPECIFIC INFORMATION ON DATES OF TESTING OR ACTUAL TEST RESULTS. THIS MDR WAS FILED FOR ONE DATE OF TESTING ((B)(6) 2020). IF SIEMENS BECOMES AWARE OF ADDITIONAL DATES OF TESTING AND/OR SPECIFIC TEST RESULTS, ADDITIONAL MDRS WILL BE FILED, AS APPROPRIATE THE FOLLOWING WERE NOTED: SAMPLES FOR CONFIRMATORY TESTING OF THE PATIENTS WITH POSITIVE RESULTS WERE EXTRACTED FROM THE ORIGINAL NASAL SWABS WHICH WERE INITIALLY EXTRACTED FOR THE FTD SARS-COV-2 TESTS. THE CONFIRMATORY METHOD USED BY THE CUSTOMER IS SIGNIFICANTLY LESS SENSITIVE THAN THE FTD SARS-COV-2 TEST WHICH PRODUCED THE POSITIVE RESULTS CONSIDERED DISCORDANT. 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. WHEN THE PATIENTS WERE RE-TESTED AFTER A FEW DAYS, THEIR VIRAL LOADS MAY HAVE DECREASED TO FALL BELOW THE LOD OF EITHER ASSAY. 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

    THE CUSTOMER HAS OBTAINED 14 POSITIVE PATIENT RESULTS USING THE FTD SARS-COV-2 ASSAY WHICH WERE NOT CONFIRMED WHEN THE SAMPLES WERE RETESTED USING AN ALTERNATE METHOD. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE POSITIVE RESULTS FROM THE FTD SARS-COV-2 ASSAY WERE 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
    1525094 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID, PRODUCT CODE: QJR QJR FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO. N/A SC20-96-47 05400829005906

    Patients

    Seq Age Sex Outcome Treatment
    1