BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 (EUA)

    MDR report key: 14690198 · Received June 14, 2022

    Report

    Report Number
    3010097867-2022-00013
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    August 24, 2020
    Report Date
    June 14, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TUCSON MEDICAL CENTER REPORTED DISCREPANT ASSAY RESULT - THE T2SARS-COV-2 PANEL (EUA) RUN ON T2DX INSTRUMENT ISA0820000215 PRODUCED A NEGATIVE RESULT, COMPARED TO THE POSITIVE SARS-COV-2 RESULT FROM THE CEPHEID GENEXPERT. THE CUSTOMER RAN QC POSITIVE AND NEGATIVE SAMPLES ON THE T2DX AND CONFIRMED INSTRUMENT PERFORMANCE WITH THE T2SARS-COV-2 PANEL. 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

    ON (B)(6) 2020, A CUSTOMER REPORTED THAT THE T2SARS-COV-2 PANEL REPORTED A NEGATIVE RESULT. THE SAME SAMPLE REPORTED A POSITIVE RESULT ON THE CEPHEID GENEXPERT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909321 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