BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12808057 · Received November 12, 2021

    Report

    Report Number
    1221359-2021-03497
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    December 5, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS OF THE INITIAL REPORT. PLEASE SEE CORRECTED FIELDS: C, D1, D2, D3, G1, G4, G6 AND H2.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TECHNICAL SERVICES STATED THAT THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL. IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ADVICE: THE SAFETY DATA SHEET WAS PROVIDED TO THE CUSTOMER. AN ADVERSE PHYSICOCHEMICAL, HUMAN HEALTH AND ENVIRONMENTAL EFFECTS REVIEW WAS PERFORMED: TO OUR KNOWLEDGE, THIS PRODUCT DOES NOT PRESENT ANY PARTICULAR RISK, PROVIDED IT IS HANDLED IN ACCORDANCE WITH GOOD OCCUPATIONAL HYGIENE AND SAFETY PRACTICE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE USER REPORTS INSERTING THE BINAXNOW COVID-19 ANTIGEN SELF TEST SWAB INTO THE NOSE WITH SOLUTION ON THE SWAB. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706114 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCABOROUGH 156715A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female