BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID19 HT COMBO KIT

    MDR report key: 11427412 · Received March 7, 2021

    Report

    Report Number
    3003673482-2019-00005
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 10, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION OF THE CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED 3 OUT OF 4 PLATES FAILED DUE TO AMPLICON CONTAMINATION IN THE NEGATIVE CONTROL WELL, WHICH INVALIDATED THE RESULTS. THE FOURTH RUN WAS VALID AND RESULTED IN 76 POSITIVE RESULTS OUT OF 94 SAMPLES. THE POSITIVE CALLS CANNOT BE DISTINGUISHED BETWEEN FALSE POSITIVE AND TRUE POSITIVE BECAUSE OF POSITIVE AMPLICON CONTAMINATION. THE PLATE FAILURES WERE DUE TO AMPLICON CONTAMINATION IN THE LABORATORY. OUR INVESTIGATION DETERMINED THAT THE CUSTOMER'S IMPROPER SEALING OF PLATE WAS THE ROOT CAUSE FOR THE AMPLICON CONTAMINATION. THE LABORATORY WAS DECONTAMINATED WITH THE HELP OF THE THERMO FISHER REPRESENTATIVE AND SUBSEQUENT RUN CONFIRMED TRUE NEGATIVE RESULTS. THE CUSTOMER WAS ADVISED TO ENSURE PROPER PLATE SEALING PRIOR TO THE RUN TO HELP PREVENT RECURRENCE OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION OF THE CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED 3 OUT OF 4 PLATES FAILED DUE TO AMPLICON CONTAMINATION IN THE NEGATIVE CONTROL WELL. A VALID RUN RESULTED IN 76 POSITIVE RESULTS OUT OF 94 SAMPLES. THE POSITIVES CANNOT BE DISTINGUISHED BETWEEN FALSE POSITIVE AND TRUE POSITIVE BECAUSE OF POSITIVE AMPLICON CONTAMINATION. THE PLATE FAILURES WERE DUE TO AMPLICON CONTAMINATION IN THE LABORATORY. OUR INVESTIGATION DETERMINED THAT THE CUSTOMER'S IMPROPER SEALING OF PLATE WAS THE ROOT CAUSE FOR THE AMPLICON CONTAMINATION. THE LABORATORY WAS DECONTAMINATED WITH THE HELP OF THE THERMO FISHER REPRESENTATIVE AND SUBSEQUENT RUN CONFIRMED NEGATIVE RESULTS. THE CUSTOMER WAS ADVISED TO ENSURE PROPER PLATE SEALING PRIOR TO THE RUN. CORRECTION ON MARCH 10, 2021: THIS MDR WAS SENT PREVIOUSLY TO FDA ON MARCH 5, 2021 UNDER THE WRONG MFR REPORT NUMBER 3003673482-2019-00005, WHICH INCLUDED AN INCORRECT FEI NUMBER AND YEAR. A NEW MDR CONTAINING THE SAME INFORMATION WILL BE SUBMITTED WITH THE CORRECT IDENTIFYING INFORMATION, UNDER MFR REPORT NUMBER 3009976420-2021-00005.

    Description of Event or Problem · 1

    WHILE UTILIZING AN RESEARCH USE ONLY (RUO) WORKFLOW WHICH INCLUDES RUO HARDWARE AND ASSAY COMPONENTS, AMPLICON CONTAMINATION IN THE USERS LABORATORY LED TO FALSE POSITIVE RESULTS. ON (B)(6) 2021, THE CUSTOMER REPORTED NEGATIVE CONTROL FAILURE AND FALSE POSITIVE RESULTS WHILE RUNNING THE TAQPATH¿ COVID-19 HT COMBO KIT. THE CUSTOMER SUPPLIED DATA FILES SHOWED EVIDENCE OF AMPLICON CONTAMINATION IN THE LAB RESULTING FALSE POSITIVE RESULTS AND FAILURE OF THE NEGATIVE CONTROL DUE TO PRESENCE OF AMPLICON IN CONTAMINATED WELLS. A THERMO FISHER REPRESENTATIVE HELPED THE CUSTOMER TO DECONTAMINATE THE LAB AND THE SUBSEQUENT RUN SHOWED NEGATIVE RESULTS FOR THE NEGATIVE CONTROLS. OUR INVESTIGATION DETERMINED THE ROOT CAUSE OF THE AMPLICON CONTAMINATION TO BE IMPROPER SEALING OF THE PLATE BY THE CUSTOMER. THERMO FISHER ADVISED THE CUSTOMER TO DO PROPER SEALING PRIOR TO THE RUN. THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES TO THERMO FISHER. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT THE FALSE RESULTS WERE REPORTED TO PHYSICIANS/PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325940 TAQPATH COVID19 HT COMBO KIT TAQPATH¿ COVID19 HT COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2044310

    Patients

    Seq Age Sex Outcome Treatment
    1