BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10623314 · Received October 2, 2020

    Report

    Report Number
    3009976420-2020-00025
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 2, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THE CUSTOMER SUPPLIED SOFTWARE DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED THREE (3) FALSE POSITIVE PATIENT SAMPLE CALLS: TWO (2) SAMPLES IN DATA FILES TAQPATH COVID-19 KIT (B)(4) AND TAQPATH COVID-19 KIT (B)(4) SHOWS BEAD CARRYOVER DURING WORKFLOW DUE TO IMPROPER VORTEXING, CAUSING FALSE POSITIVE CALLS IN PATIENT SAMPLES. THE ROOT CAUSE OF THIS ISSUE WAS IDENTIFIED AS POSSIBLE BEAD CARRYOVER DUE TO IMPROPER VORTEXING. ONE (1) SAMPLE IN DATA FILE TAQPATH COVID-19 KIT (B)(4) SHOWS A LARGE BUBBLE IN LATE THERMAL CYCLING. THE ROOT CAUSE OF THIS ISSUE WAS IDENTIFIED AS IMPROPER MIXING AND CENTRIFUGATION OF THE QPCR PLATE IN ORDER TO RELEASE TRAPPED AIR BUBBLES.

    Description of Event or Problem · 1

    IMPROPER VORTEXING AND CENTRIFUGATION LED TO FALSE POSITIVE COVID-19 RESULTS. ON (B)(6) 2020, (B)(6) REPORTED SUSPECTED FALSE POSITIVE COVID-19 RESULTS TO THERMO FISHER SCIENTIFIC. DURING COMPLAINT INVESTIGATION, THE CUSTOMER SUBSEQUENTLY REPORTED 2 ADDITIONAL INSTANCES ON (B)(6) 2020 AND (B)(6) 2020, ALL OF WHICH WERE INVESTIGATED IN THE PRIMARY COMPLAINT RECORD. IN TOTAL, THE CUSTOMER PROVIDED 4 SOFTWARE DATA LOG FILES DATED (B)(6) 2020. THE CUSTOMER-SUPPLIED DATA FILES SHOWED EVIDENCE OF BEAD CARRYOVER AND BUBBLES IN THE REACTION WELLS, INDICATIVE OF INADEQUATE VORTEXING AND CENTRIFUGATION. THERMO FISHER'S FIELD SERVICE SPECIALIST INSTRUCTED THE CUSTOMER TO VORTEX THE QPCR PLATE PROPERLY AND PROPERLY CENTRIFUGING PER THE INSTRUCTIONS FOR USE TO HELP PREVENT RECURRENCE OF THE ISSUE. THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC. 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
    1083500 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1