BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13319120 · Received January 21, 2022

    Report

    Report Number
    1221359-2022-00473
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    December 22, 2021
    Report Date
    May 10, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. A PRODUCT DEFICIENCY WAS NOT REPORTED OR FOUND. THE CUSTOMER WAS PROVIDED WITH THE REAGENT SAFETY DATA SHEET (SDS). ACCORDING TO THE PACKAGE INSERT IN195000 V. 3.0. PRECAUTIONS: 21. THE EXTRACTION REAGENT PACKAGED IN THIS KIT CONTAINS SALINE, DETERGENTS AND PRESERVATIVES THAT WILL INACTIVATE CELLS AND VIRUS PARTICLES. SAMPLES ELUTED IN THIS SOLUTION ARE NOT SUITABLE FOR CULTURE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER/PATIENT REPORTED ACCIDENTALLY PUTTING THE BINAXNOW COVID-19 EXTRACTION REAGENT IN THEIR EYES AS THEY THOUGHT IT WAS THEIR EYES DROPS. THE CUSTOMER FLUSHED THEIR EYES IMMEDIATELY AND CONFIRMED THAT NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948403 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 140141 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other