BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13757596 · Received March 14, 2022

    Report

    Report Number
    1221359-2022-01425
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    February 17, 2022
    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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE INVESTIGATION CONCLUSION. TECHNICAL SERVICES PROVIDED THE CUSTOMER WITH THE SAFETY DATA SHEET (SDS) AND NO FURTHER ACTHTTPS://EMDR.FDA.GOV/EMDR/FORMQCREDACTION/ION IS REQUIRED. ACCORDING TO THE PACKAGE INSERT IN195000 V. 3.0: PRECAUTIONS: 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. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT THE BINAXNOW COVID-19 AG CARD EXTRACTION REAGENT CAME IN CONTACT WITH HER EYES ON (B)(6) 2022. THE CONSUMER CONFIRMED THAT THERE WAS NO HARM DUE TO THE EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338190 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other