BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2CANDIDA 1.1 PANEL

    MDR report key: 15512044 · Received September 30, 2022

    Report

    Report Number
    3010097867-2022-00032
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 20, 2022
    Report Date
    September 29, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    PII
    PMA / PMN Number
    K173536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE T2CANDIDA 1.1 PANEL RESULTED IN A POSITIVE CANDIDA PARAPSILOSIS RESULT ON A NEGATIVE CLINICAL SAMPLE USING T2DX INSTRUMENT I(B)(4). THE CUSTOMER REPORTED THE FALSE POSITIVE RESULT AS COMPARED TO NEGATIVE BLOOD CULTURE OF THE SAME VENOUS COLLECTION. PATIENT DETAILS WERE NOT PROVIDED. BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR, THERE WAS NO ALLEGATION FROM THE INSTITUTION THAT THE ALLEGED FALSE POSITIVE LED TO AN ADVERSE EVENT OR PATIENT HARM. SPECIFIC RUN DATA WAS TRANSFERRED TO T2 BIOSYSTEMS FOR REVIEW/EVALUATION AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CLINIC ON 13SEP2022; THE T2CANDIDA 1.1 PANEL AND ASSOCIATED BLOOD SAMPLES WERE DISCARDED AFTER USE. REVIEW OF THE DESIGN HISTORY RECORDS OF THE ASSOCIATED T2CANDIDA 1.1 LOT (WO-20913) RESULTED IN NO FINDINGS RELATED TO PRODUCT QUALITY. FSE OBSERVATION OF THE CUSTOMER'S SAMPLE PREPARATION METHODS SUGGESTED PROCEDURES THAT DEVIATED FROM THE IFU. T2 BIOSYSTEMS SERVICE ADVISED ON BEST PRACTICES FOR SAMPLE HANDLING AND INSTRUMENT MAINTENANCE ACCORDING TO THE IFU AND OPERATOR MANUAL.

    Description of Event or Problem · 0

    ON 30 AUGUST 2022, A T2 DISTRIBUTOR RELAYED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE RESULT USING THE T2CANDIDA 1.1 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885257 T2CANDIDA 1.1 PANEL CANDIDA SPECIES NUCLEIC ACID DETECTION SYSTEM PII T2 BIOSYSTEMS, INC T2CANDIDA 1.1 PANEL WO-20913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown