BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 12849934 · Received November 21, 2021

    Report

    Report Number
    1221359-2021-03362
    Event Type
    Injury
    Date Received
    November 21, 2021
    Report Date
    May 4, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER. ACCORDING TO THE PACKAGE INSERT IN195000 V 3.0 PRECAUTIONS THE EXTRACTION REAGENT PACKAGED IN THIS KIT CONTAINS SALINE, DETERGENTS AND PRESERVATIONS THAT WILL INACTIVATE CELLS AND VIRUS PARTICLES. SAMPLES ELUTED IN THIS SOLUTION ARE NOT SUITABLE FOR CULTURE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA : B5, G3, E3, H2.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE USER REPORTED ACCIDENTALLY USING THE REAGENT AS EYEDROPS. PER USER, EYE WAS IRRITATED . THE USER WAS ADVISED TO IMMEDIATELY FLUSH EYES WITH WATER FOR 15 MINUTES.

    Description of Event or Problem · 0

    THE USER REPORTED ACCIDENTALLY USING THE REAGENT AS EYEDROPS. THE USER WAS ADVISED TO IMMEDIATELY FLUSH EYES WITH WATER FOR 15 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747817 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCABOROUGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other