BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 (EUA)

    MDR report key: 14690201 · Received June 14, 2022

    Report

    Report Number
    3010097867-2022-00022
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    April 19, 2022
    Report Date
    June 14, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A COURTESY SITE VISIT ON (B)(6) 2022, A (B)(6) HOSPITAL REPRESENTATIVE COMMENTED THAT DURING CORRELATION TESTING, A FEW CEPHEID GENEXPERT POSITIVE SAMPLES TESTED NEGATIVE WITH THE T2SARS-COV-2 PANEL (EUA). CEPHEID CT VALUES WERE EVALUATED FOR THOSE REPORTING NEGATIVE ON T2DX INSTRUMENT ISA1621000279. T2SARS-COV-2 PANEL NEGATIVE RESULTS WERE DETERMINED TO BE BELOW THE LIMIT OF DETECTION FOR THE ASSAY. THE CEPHEID GENEXPERT ASSAY IS MORE SENSITIVE IN SARS-COV-2 DETECTION THAN THE T2SARS-COV-2 PANEL AND LIKELY THE CAUSE FOR DISCREPANT RESULTS.

    Description of Event or Problem · 0

    DURING A COURTESY SITE VISIT ON (B)(6) 2022, A (B)(6) HOSPITAL REPRESENTATIVE COMMENTED THAT DURING CORRELATION TESTING, A FEW CEPHEID GENEXPERT POSITIVE SAMPLES TESTED NEGATIVE WITH THE T2SARS-COV-2 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909323 T2SARS-COV-2 (EUA) MOLECULAR DIAGNOSTIC TEST FOR SARS-COV-2 QJR T2 BIOSYSTEMS, INC T2SARS-COV-2 PANEL (EUA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown