BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14420946 · Received May 17, 2022

    Report

    Report Number
    1221359-2022-02752
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 21, 2022
    Report Date
    August 4, 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
    003

    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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 184029 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 184029 AND TEST BASE PART NUMBER 195-430H / LOT 180914. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (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. ALSO, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION FOR TWO OF THE TEST KITS PERFORMED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST USING ONE LOT. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 21APR2022 ON A NASAL SAMPLE USING THE KIT SWAB. CONFIRMATION TESTING VIA AN UNKNOWN RAPID PLATFORM PERFORMED AT A HEALTHCARE PROVIDER'S OFFICE ON 21APR2022 GENERATED POSITIVE RESULTS. THE CONSUMER WAS REPORTEDLY SYMPTOMATIC AND RECEIVED TREATMENT FOR COVID-19. THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908544 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 184029 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female