BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10590657 · Received September 25, 2020

    Report

    Report Number
    3009976420-2020-00024
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 26, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS RUNNING SAMPLES ON A QUANT STUDIO 12K FLEX INSTRUMENT PLATFORM. WHILE THE QUANT STUDIO 12K FLEX IS A THERMO FISHER SCIENTIFIC INSTRUMENT, IT IS NOT AN AUTHORIZED PLATFORM FOR OUR COVID-19 WORKFLOW. OUR INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING GUIDANCE: AUTHORIZED LABORATORIES USING THE TAQPATH¿ COVID-19 COMBO KIT WILL PERFORM THE TAQPATH¿ COVID-19 COMBO KIT AS OUTLINED IN THE TAQPATH¿ COVID-19 COMBO KIT INSTRUCTIONS FOR USE. DEVIATIONS FROM THE AUTHORIZED PROCEDURES, INCLUDING THE AUTHORIZED INSTRUMENTS, AUTHORIZED EXTRACTION METHODS, AUTHORIZED CLINICAL SPECIMEN TYPES, AUTHORIZED CONTROL MATERIALS, AUTHORIZED OTHER ANCILLARY REAGENTS, AND AUTHORIZED MATERIALS REQUIRED TO PERFORM THE TAQPATH¿ COVID-19 COMBO KIT ARE NOT PERMITTED. THEREFORE, THE CUSTOMER'S WORKFLOW CONSTITUTES A LABORATORY DEVELOPED TEST, AND IT IS THE CUSTOMER'S RESPONSIBILITY TO VALIDATE THEIR WORKFLOW AND TO ESTABLISH APPROPRIATE CUT-OFF VALUES. THE ANALYSIS OF THE CUSTOMER'S DATA BY THERMO FISHER SCIENTIFIC'S TECHNICAL AND FIELD APPLICATION SCIENTIST TEAM REVEALED ISSUES WITH POOR VORTEXING AND CENTRIFUGATION OF THE QPCR PLATE, AND CONFIRMED ZERO (0) FALSE POSITIVE RESULTS DUE TO THE LACK OF AN ESTABLISHED, VALIDATED THRESHOLD. THE CUSTOMER WAS INSTRUCTED TO FOLLOW INSTRUCTIONS FOR USE REGARDING PROPER VORTEXING, CENTRIFUGING, AND PROPER HANDLING OF REAGENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THERMO FISHER SCIENTIFIC WAS CONTACTED BY THE (B)(6), NOTIFYING US OF A CUSTOMER (B)(6) THAT REPORTED TO THEM FALSE POSITIVE RESULTS, FROM THE TAQPATH COVID-19 KIT RUN ON (B)(6) 2020. THERMO FISHER CONTACTED THE CUSTOMER, WHO INDICATED THEY REPORTED TO THE DOH 30 FALSE POSITIVES AND 7 PRESUMPTIVE POSITIVES. CUSTOMER STATED PATIENTS WERE RE-SWABBED SAME DAY, AND THE SAMPLES WERE RE-TESTED BY (B)(6), WHICH DETERMINED THE RESULTS WERE TRUE NEGATIVE. CUSTOMER IS RUNNING SAMPLES ON A QUANT STUDIO 12K FLEX INSTRUMENT PLATFORM. WHILE THE QUANT STUDIO 12K FLEX IS A THERMO FISHER SCIENTIFIC INSTRUMENT, IT IS NOT AN AUTHORIZED PLATFORM FOR OUR COVID-19 WORKFLOW. THERMO FISHER'S FIELD SERVICE SPECIALIST INSTRUCTED THE CUSTOMER TO VORTEX THE QPCR PLATE PROPERLY PER THE INSTRUCTIONS FOR USE AND TO KEEP THEY ASSAY MIX REAGENTS ON ICE. THE CUSTOMER REPORTED SEEING CONSISTENCY IN THEIR DATA SINCE IMPLEMENTING THE PROPER VORTEXING TECHNIQUE AND IN-PROCESS STORAGE OF THE MIX REAGENTS. LAB REPORTED NO FINDINGS OF CONTAMINATION. THE CUSTOMER DID NOT REPORT ANY DEATHS, OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT FALSE POSITIVE RESULTS WERE REPORTED TO PHYSICIANS/PATIENTS, HOWEVER, (B)(6) WERE ABLE TO CONFIRM TRUE NEGATIVE RESULTS ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053189 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1