BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 (EUA)

    MDR report key: 14690214 · Received June 14, 2022

    Report

    Report Number
    3010097867-2022-00014
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    September 4, 2020
    Report Date
    June 14, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) MEDICAL CENTER REPORTED DISCREPANT ASSAY RESULTS DURING ASSAY VALIDATION - THE T2SARS-COV-2 PANEL (EUA), LOT WO-10199/EXPIRY 02/04/2021 RUN ON T2DX INSTRUMENT IS A1415000043 PRODUCED A NEGATIVE RESULT ON (B)(6) 2020, COMPARED TO THE POSITIVE SARS-COV-2 RESULT FROM THE CEPHEID GENEXPERT RUN ON (B)(6) 2020. THIS IS THE FIRST OF FIVE DISCREPANT NEGATIVE RESULTS OBTAINED DURING VALIDATION, WITH THE UNIQUE RUN ID: (B)(6). THE CUSTOMER RAN QC ON THE T2DX AND CONFIRMED INSTRUMENT PERFORMANCE. THE CEPHEID GENEXPERT ASSAY IS MORE SENSITIVE IN SARS-COV-2 DETECTION THAN THE T2SARS-COV-2 PANEL AND LIKELY CAUSE FOR THE DISCREPANT RESULT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909326 T2SARS-COV-2 (EUA) MOLECULAR DIAGNOSTIC TEST FOR SARS-COV-2 QJR T2 BIOSYSTEMS, INC T2SARS-COV-2 PANEL (EUA) WO-10199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown