BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN CARD

    MDR report key: 13321342 · Received January 21, 2022

    Report

    Report Number
    1221359-2022-00479
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    December 24, 2021
    Report Date
    May 11, 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE INVESTIGATION CONCLUSION. TECHNICAL SERVICES ATTEMPTED TO REACH OUT TO THE CUSTOMER TO SEE IF THEY REQUIRED ANY ADDITIONAL MEDICAL ATTENTION BUT WERE UNSUCCESSFUL. 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 SHE ACCIDENTLY INGESTED THE REAGENT SOLUTION FROM THE BINAXNOW COVID-19 ANTIGEN CARD TEST KIT ON (B)(6) 2021. THE CONSUMER RINSED HER MOUTH OUT WITH WATER. THE CONSUMER CALLED TECHNICAL SERVICES (TS) FOR GUIDANCE ON THE ACCIDENTAL INGESTION CONCERN. TS CONFERENCED IN A POISON & DRUG CENTER REPRESENTATIVE TO PROVIDE MEDICAL ADVICE TO THE CONSUMER. TS EMAILED A COPY OF THE REAGENT SAFETY DATA SHEET PRIOR TO DROPPING OFF THE CALL DUE TO PRIVACY REASONS. THE CONSUMER CONFIRMED THAT SHE WAS NOT EXPERIENCING ANY FURTHER ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902424 BINAXNOW COVID-19 ANTIGEN CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other