BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13177513 · Received January 6, 2022

    Report

    Report Number
    1221359-2022-00137
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    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 COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 172611 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160/ LOT 172611 AND TEST BASE PART NUMBER 195-430H/ LOT 167264. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE CURRENT OVERALL INCIDENT RATE FOR FALSE 172611 PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANITGEN SELF TEST. THE CONSUMER REPORTED A POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST. REPEAT TESTING WAS PERFORMED ON THE SAME DAY AND GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56893 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 172611 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown