BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT

    MDR report key: 11435050 · Received March 5, 2021

    Report

    Report Number
    MW5099818
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 5, 2021
    Manufacturer
    PERKINELMER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE RESULTS WERE REPORTED FOR PTS TESTED WITH PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT BATCH(S) (LOT NUMBER) K20030 AND K2005; REPORTED OVER 100 FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323225 NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT EAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR PERKINELMER, INC. K2005
    323226 NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR PERKINELMER, INC. K20030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other