BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13233745 · Received January 11, 2022

    Report

    Report Number
    1221359-2022-00131
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 16, 2021
    Report Date
    May 10, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICES ADVISED THE USER TO SEEK MEDICAL TREATMENT IF IRRITATION OCCURED. TECHNICAL SERVICES PROVIDED THE USER THE SAFETY DATA SHEET OF THE REAGENT THROUGH EMAIL. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ANY ADDITIONAL IS OBTAINED.

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICES ADVISED THE USER TO SEEK MEDICAL TREATMENT IF IRRITATION OCCURED. TECHNICAL SERVICES PROVIDED THE USER THE SAFETY DATA SHEET OF THE REAGENT THROUGH EMAIL. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ANY ADDITIONAL IS OBTAINED.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. ACCORDING TO THE PACKAGE INSERT IN195150 V. 3.0: PRECAUTIONS: THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL. IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE USER REPORTED SQUIRTING SOME OF THE BINAXNOW COVID-19 REAGENT SOLUTION AS DROPS IN HER EYE, SHE JUST WASHED IT WITH WATER AND WAS ALRIGHT. THE USER ALSO, QUESTIONED IF WHETHER OR NOT SHE SHOULD INSERT THE SWAB WITH MUCUS ON IT FOR TESTING. THE USER DID NOT SEEK MEDICAL ATTENTION AND NO SERIOUS INJURY OCCURED.

    Description of Event or Problem · 0

    THE USER REPORTED SQUIRTING SOME OF THE BINAXNOW COVID-19 REAGENT SOLUTION AS DROPS IN HER EYE, SHE JUST WASHED IT WITH WATER AND WAS ALRIGHT. THE USER ALSO, QUESTIONED IF WHETHER OR NOT SHE SHOULD INSERT THE SWAB WITH MUCUS ON IT FOR TESTING. THE USER DID NOT SEEK MEDICAL ATTENTION AND NO SERIOUS INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738130 BINAX NOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 148779

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other