BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 (EUA)

    MDR report key: 14690221 · Received June 14, 2022

    Report

    Report Number
    3010097867-2022-00023
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    March 12, 2022
    Report Date
    June 14, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) HOSPITAL REPORTED DISCREPANT ASSAY RESULTS DURING A CORRELATION STUDY PERFORMED AS A PART OF ASSAY VALIDATION - THE T2SARS-COV-2 PANEL (EUA) RUN ON T2DX INSTRUMENT ISA1621000278 PRODUCED A NEGATIVE RESULT ON (B)(6) 2022, COMPARED TO THE POSITIVE SARS-COV-2 RESULT FROM THE CEPHEID GENEXPERT RUN ON THE SAME DATE. THIS IS THE FIRST OF FIVE DISCREPANT NEGATIVE RESULTS. THIS SAMPLE WAS RUN ON (B)(6) 2022, WITH THE UNIQUE RUN ID: (B)(6). THE CUSTOMER RAN QC ON THE T2DX INSTRUMENT AS DEFINED IN THE T2SARS-COV-2 PANEL IFU, WITH 5/5 REPORTED FOR POSITIVE CONTROLS AND 4/5 REPORTED FOR NEGATIVE CONTROLS. 1/5 NEGATIVE CONTROLS RESULTED IN AN INVALID. 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) 2022, A (B)(6) HOSPITAL REPRESENTATIVE REPORTED THAT THE T2SARS-COV-2 PANEL RESULTED IN FIVE NEGATIVE RESULTS ON A KNOWN POSITIVE SAMPLE DURING SYSTEM VALIDATION. THE SAMPLES TESTED POSITIVE ON THE CEPHEID GENEXPERT FOR SARS-COV-2 JUST BEFORE NEGATIVE DETECTION WITH THE T2SARS-COV-2 PANEL ON THE T2DX INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735895 T2SARS-COV-2 (EUA) MOLECULAR DIAGNOSTIC TEST FOR SARS-COV-2 QJR T2 BIOSYSTEMS, INC T2SARS-COV-2 PANEL (EUA) WO-20555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown