BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 11828077 · Received May 14, 2021

    Report

    Report Number
    3009976420-2021-00022
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    March 31, 2021
    Report Date
    May 14, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERMO FISHER SCIENTIFIC WAS UNABLE TO CONFIRM THE INITIAL REPORT OF A SUSPECTED FALSE POSITIVE RESULT FROM (B)(6) 2020 DUE TO DATA FILES NOT BEING PROVIDED FOR INVESTIGATION. DURING REVIEW OF THE CUSTOMER-PROVIDED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED ONE (1) FALSE POSITIVE PATIENT RESULT FROM THE FILE DATED (B)(6) 2021 WHICH WAS INDUCED BY A BUBBLE EVENT. THERMO FISHER SCIENTIFIC CONCLUDED TWO POTENTIAL ROOT CAUSES OF INADEQUATE VORTEXING AND CENTRIFUGATION. IFU MAN0019181 CONTAINS THE WARNING: "IMPORTANT! VORTEX FOR 10-30 SECONDS TO ENSURE PROPER MIXING. FAILURE TO DO SO MIGHT RESULT IN FALSE CLASSIFICATION OF SAMPLES." THE CUSTOMER WAS INSTRUCTED TO FOLLOW THE VORTEXING AND CENTRIFUGATION INSTRUCTIONS IN OUR INSTRUCTIONS FOR USE TO HELP PREVENT REOCCURRENCE OF THE ISSUE. THERMO FISHER SCIENTIFIC HAS MADE THREE ATTEMPTS TO CONFIRM IF THE IDENTIFIED FALSE POSITIVE FOUND FROM THE UNRELATED DATA FILE WAS REPORTED OUT TO THE PHYSICIAN AND/OR THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. IF ANY NEW OR SIGNIFICANT INFORMATION IS PROVIDED LATER, WE WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ON APRIL 16, 2021 THERMO FISHER RECEIVED A REPORT THAT THE CUSTOMER WAS CONCERNED ABOUT SOME TESTING PERFORMED IN (B)(6) 2020 WHILE RUNNING THE TAQPATH¿ COVID19 COMBO KIT. IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT WAS TESTED AS NEGATIVE AND ON (B)(6) 2020 THE SAME PATIENT WAS TESTED AS POSITIVE. PRIOR TO BEING MOVED TO AN UNSPECIFIED LOCATION WITHIN THE FACILITY THE PATIENT WAS RETESTED ON (B)(6),2020 AND THE RESULT WAS FOUND TO BE NEGATIVE, WHICH LED THE CUSTOMER TO BELIEVE THAT THE POSITIVE RESULT ON (B)(6) WAS A FALSE POSITIVE. THE REPORTER INDICATED THAT THE DATA FILE FOR THE ORIGINAL SUSPECTED FALSE POSITIVE FROM (B)(6) 2020 COULD NOT BE FOUND AND THEREFORE THERMO FISHER COULD NOT CONFIRM THE INITIAL COMPLAINT EVENT. HOWEVER, THE CUSTOMER PROVIDED DATA FILES FOR TWO RUNS IN (B)(6) 2021 AND ONE FROM (B)(6) 2020, WHICH WERE UNRELATED TO THE COMPLAINT EVENT. AFTER REVIEW OF THE FILES SENT FROM THE CUSTOMER, THE FILE FROM (B)(6) 2021 WAS FOUND TO HAVE ONE FALSE POSITIVE PATIENT RESULT IN IT. NO DEATHS OR SERIOUS INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721361 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1