BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT

    MDR report key: 12576193 · Received October 4, 2021

    Report

    Report Number
    MW5104369
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Report Date
    September 30, 2021
    Manufacturer
    PERKINELMER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): WE HAVE IDENTIFIED AN ISSUE WITH THE BD UNIVERSAL VIRAL TRANSPORT MEDIUM FOR VIRUSES, CHLAMYDIAE, MYCOPLASMAS, UREAPLASMAS AND THE PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT. WE WERE ALERTED TO THIS ISSUE WHEN A SUBMITTER TRANSITIONED TO USING THE BD UTM AND WE IMMEDIATELY SAW AN INCREASE IN THE NUMBER OF INVALID RESULTS. WE HAVE INVESTIGATED THOROUGHLY AND HAVE COME TO THE CONCLUSION THAT IT'S THIS PARTICULAR MEDIA THAT IS CAUSING THE ISSUE. THE RESULTS ARE REPEATABLE FOLLOWING RE-EXTRACTION. THE 2 LOTS WE HAVE TESTED ARE: BD/N101148 AND BD/N100701. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464334 PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC QJR PERKINELMER, INC.
    1464336 THE BD UNIVERSAL VIRAL TRANSPORT MEDIUM FOR VIRUSES, CHLAMYDIAE, MYCOP CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM COPAN DIAGNOSTICS, INC. BD/ N101148
    1464337 THE BD UNIVERSAL VIRAL TRANSPORT MEDIUM FOR VIRUSES, CHLAMYDIAE, MYCOP CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM COPAN DIAGNOSTICS, INC. BD/ N100701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other