BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13535124 · Received February 15, 2022

    Report

    Report Number
    1221359-2022-00978
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 20, 2022
    Report Date
    June 9, 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 COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. RELATED REPORT: 1221359-2022-00977.

    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 175954 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 195-160/LOT 175954 AND DEVICE PART NUMBER 195-430H / LOT 171800. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST, USING NASAL SWAB SAMPLES. THE FIRST ANTIGEN SELF TEST WAS PERFORMED ON (B)(6) 2022, WHICH GENERATED A NEGATIVE RESULT. CONFIRMATION RT-PCR TESTING WAS PERFORMED ON (B)(6) 2022, USING AN UNKNOWN SAMPLE TYPE, WHICH GENERATED A POSITIVE RESULT. CT VALUES WERE NOT PROVIDED FOR THIS RT-PCR TEST. THE CONSUMER THEN TOOK A SECOND ANTIGEN SELF TEST WHICH WAS PERFORMED ON (B)(6) 2022, THAT GENERATED A NEGATIVE RESULT. THE CONSUMER STATED THAT SHE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THIS MANUFACTURER REPORT ADDRESSES FALSE NEGATIVE RESULT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585944 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 175954 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown