BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 (EUA)

    MDR report key: 14690227 · Received June 14, 2022

    Report

    Report Number
    3010097867-2022-00020
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 3, 2021
    Report Date
    June 14, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DOOR COUNTY MEDICAL CENTER REPRESENTATIVE REPORTED A DISCREPANT ASSAY RESULT - THE T2SARS-COV-2 PANEL (EUA) RUN ON T2DX INSTRUMENT ISA46160000100 PRODUCED A POSITIVE RESULT. THREE HOURS LATER, A SECOND SWAB FROM THE SAME PATIENT TESTED NEGATIVE WITH THE T2SARS-COV-2 PANEL ON A DIFFERENT T2DX INSTRUMENT. THE DOOR COUNTY REPRESENTATIVE CONFIRMED THAT NO QC WAS RUN ON THE DAY THAT THE SAMPLES WERE COLLECTED AND RUN, SO THE FALSE POSITIVE WAS NOT ASSOCIATED WITH A QC SAMPLE MIX UP. THE RUN IDS WERE PROVIDED TO T2 FOR ANALYSIS OF THE DIAGNOSTIC FILES. PRESSURE DATA FROM BOTH RUNS WAS CONSISTENT WITH T2DX INSTRUMENT OPERATION WITHOUT ISSUE. T2 RECOMMENDED DOOR COUNTY RUN POSITIVE AND NEGATIVE EXTERNAL CONTROLS ON BOTH T2DX INSTRUMENTS AND REPORT ANY FURTHER ISSUES. NO FURTHER FOLLOW UP WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    ON 4 JUNE 2021, A DOOR COUNTY MEDICAL CENTER REPRESENTATIVE REPORTED A DISCREPANT ASSAY RESULT THE T2SARS COV-2 PANEL (EUA) RUN ON T2DX INSTRUMENT ISA46160000100 PRODUCED A POSITIVE RESULT. THREE HOURS LATER, A SECOND SWAB FROM THE SAME PATIENT TESTED NEGATIVE WITH THE T2SARS-COV-2 PANEL ON A DIFFERENT T2DX INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909328 T2SARS-COV-2 (EUA) MOLECULAR DIAGNOSTIC TEST FOR SARS-COV-2 QJR T2 BIOSYSTEMS, INC T2SARS-COV-2 PANEL (EUA) WO-11343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown