BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13952583 · Received March 30, 2022

    Report

    Report Number
    1221359-2022-01600
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 11, 2022
    Report Date
    May 5, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QKP
    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 INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CONSUMER REPORTED EXTRACTION REAGENT EXPOSURE IN RIGHT EYE WITH THE BINAXNOW COVID-19 AG KIT PERFORMED ON (B)(6) 2022 . NO ADDITIONAL PATIENT INFORMATION,INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104402 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other