BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13309820 · Received January 20, 2022

    Report

    Report Number
    1221359-2022-00382
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    December 22, 2021
    Report Date
    May 4, 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

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TECHNICAL SERVICES MADE ATTEMPTED TO CONTACT THE CUSTOMER BUT WAS UNSUCCESSFUL IN PROVIDING SAFETY DATA SHEET. ACCORDING TO THE PACKAGE INSERT IN195000 V3.0: PRECAUTIONS THE EXTRACTION REAGENT PACKAGED IN THIS KIT CONTAINS SALINE, DETERGENTS, AND PRESERVATIVES THAT WILL INACTIVATE CELLS AND VIRUS PARTICLE. 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 HIS (B)(6) DAUGHTER MAY HAVE INGESTED THE BINAXNOW REAGENT ON (B)(6) 2021. THE CONSUMER STATED THAT THE CHILD WAS NOT DISPLAYING ANY SYMPTOMS AT THE TIME OF THE CALL. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521002 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other