BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14720267 · Received June 16, 2022

    Report

    Report Number
    1221359-2022-00380
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    December 20, 2021
    Report Date
    June 16, 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

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4). ON RETAINED KIT LOT 161332 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 161332 AND TEST BASE PART NUMBER 195-430WL / LOT 156113. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 161332 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 CUSTOMER REPORTED A UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2021. THE CONSUMER HAD COVID-19 TESTING PERFORMED AT A "CENTER" ON (B)(6) 2021 WHICH GENERATED A POSITIVE RESULT (CONSUMER UNSURE OF THE PLATFORM BUT BELIEVED IT TO BE A "RAPID TEST"). THE CONSUMER TESTED WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2021 WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER RETESTED WITH ANOTHER BINAXNOW COVID-19 ANTIGEN SELF -TEST WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER HAD CONFIRMATION PCR TESTING PERFORMED (PLATFORM UNKNOWN) AND IS AWAITING THE RESULTS. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365305 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 161332 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female