BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG SELF TEST

    MDR report key: 12651606 · Received October 18, 2021

    Report

    Report Number
    1221359-2021-03118
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    September 24, 2021
    Report Date
    April 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: 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. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. THE CONSUMER'S FRIEND WAS PROVIDED WITH THE EXTRACTION REAGENT SAFETY DATA SHEET (SDS) AND ADVISED TO HAVE THE CONSUMER CONSULT WITH THEIR DOCTOR.

    Description of Event or Problem · 1

    THE CONSUMER'S FRIEND REPORTED THE CONSUMER ACCIDENTLY USED THE BINAXNOW COVID-19 EXTRACTION REAGENT FROM THE SELF-TEST IN HER EYES. IT WAS ALSO REPORTED THE CONSUMER EXPERIENCED EYE IRRITATION DUE TO THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547374 BINAXNOW COVID-19 AG SELF TEST LATERAL FLOW IMMUNOASSAY IVD COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other