BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14690286 · Received June 14, 2022

    Report

    Report Number
    1221359-2022-02802
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTED PUTTING REAGENT IN THE TEST CARD, INSERTING THE SWAB IN THE TEST CARD AND THEN INSERTING THE SWAB UP NOSE WHILE TESTING WITH THE BINAXNOW COVID-19 AG SELF TEST. TECHNICAL SERVICE ADVISED THE CUSTOMER THAT THE SOLUTIONS COMPONENTS AND CONCENTRATION, ALSO PROVIDED THE POISON PHONE NUMBER (800) 222-1222 IN CASE SHE HAS IRRITATION. TECHNICAL SERVICE ADVISED THE CUSTOMER TO CONTACT THEIR HEALTH CARE PROVIDER FOR FURTHER ASSISTANCE. TECHNICAL SERVICE PROVIDED THE CUSTOMER WITH THE REAGENT SOLUTION SDS. ACCORDING TO THE PACKAGE INSERT IN195150 V. 3.0: PRECAUTIONS: THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL (SEE TABLE BELOW). IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ADVICE: HTTPS://WWW.POISON.ORG/CONTACT-US OR 1-800-222-1222. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED HAVING INSERTED THE NASAL SWAB OF THE BINAXNOW COVID-19 ANTIGEN SELF-TEST INTO THE BOTTOM HOLE OF THE TEST CARD AFTER HAVING PLACED SIX DROPS OF REAGENT INTO THE TEST CARD. THE CONSUMER DID NOT REPORT ANY EFFECTS FROM BEING EXPOSED TO THE REAGENT. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836845 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 194721 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other