BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK IT

    MDR report key: 15462415 · Received September 21, 2022

    Report

    Report Number
    MW5112184
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    September 18, 2022
    Report Date
    September 19, 2022
    Manufacturer
    LUCIRA HEALTH
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5112184 ON 9/29/2022 FOR PROCODE QJR.

    Description of Event or Problem · 0

    THE SAMPLE VIAL SEAL DID NOT PEEL OPEN AS INSTRUCTED BY THE INSTRUCTIONS FOR USE. THE SAMPLE VIAL HAS A PEELABLE FOIL SEAL WITH A PEEL TAB. THE PEEL TAB REMOVED WITHOUT PEELING THE FOIL FROM THE TOP OF THE TUBE. LUCIRA CHECK IT COVID-19 TEST. TEST KIT #: (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302237 CHECK IT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUCIRA HEALTH K08A110804223M2
    775973 CHECK IT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUCIRA HEALTH K08A110804223M2

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male