BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12236586 · Received July 28, 2021

    Report

    Report Number
    1221359-2021-02119
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    July 2, 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

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES:G3, G6 AND H2. TECHNICAL SERVICES PROVIDED THE SAFETY DATA SHEET (SDS) TO THE CUSTOMER. ACCORDING TO THE PACKAGE INSERT IN195000 V3.0: 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 · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. 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 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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ACCIDENTALLY PUTTING THE BINAXNOW COVID-19 AG EXTRACTION REAGENT INTO HER EYE THINKING IT WAS HER EYES DROPS. THE CUSTOMER WAS ADVISED TO TAKE FIRST-AID MEASURES AFTER EYE CONTACT AND TO RINSE HER EYES WITH WATER AS A PRECAUTION. ALSO, WAS ADVISED TO SEEK MEDICAL ATTENTION IF SHE EXPERIENCES A REACTION. NO FURTHER INFORMATION, INCLUDING EVENT DETAILS, TREATMENT AND OUTCOME, WAS PROVIDED. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139589 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other