BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 12560997 · Received October 1, 2021

    Report

    Report Number
    1221359-2021-02908
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 9, 2021
    Report Date
    May 9, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. 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 CUSTOMER REPORTED EXTRACTION REAGENT COMING INTO CONTACT WITH EYE WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2021. PATIENT HAD PUT SOME BINAXNOW COVID-19 REAGENT IN THEIR EYES, MISTAKING THEM FOR EYE DROPS. THE PATIENT'S EYES WERE RINSED OUT WITH WATER. THE CUSTOMER CONFIRMED THERE WAS NO MEDICAL EXPOSURES OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457892 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown