BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 12691470 · Received October 25, 2021

    Report

    Report Number
    1221359-2021-03263
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 30, 2021
    Report Date
    May 10, 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

    TECHNICAL SERVICES PROVIDES SUPPORT TO THE CUSTOMER. TECHNICAL SERVICES STATED THAT THE CUSTOMER HAS TO WASH HIS NOSTRILS WITH WATER. TECHNICAL SERVICES PROVIDED THE SDS TO THE CUSTOMER. 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.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED ADDING REAGENT SOLUTION ON SWAB AND THEN SWABBING THEIR DAUGHTERS NOSTRILS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. PER THE CONSUMER, THEY CONTACTED THE PATIENT'S DOCTOR AND THEY MENTIONED NOT TO WORRY. ADDITIONALLY, THE CONSUMER'S DAUGHTER IS IN GOOD HEALTH AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585462 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 146301D

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Other