BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13197769 · Received January 7, 2022

    Report

    Report Number
    1221359-2022-00139
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 14, 2021
    Report Date
    June 6, 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

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2, AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 173466 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 195-160/195-260/ LOT 173466 AND DEVICE PART NUMBER 195-430H / LOT 170927. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO CONFLICTING RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). 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 A CONFLICTING RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2021 TESTED AS IN DIRECT NASAL KITTED SWAB. THE USER PERFORMED TWO (2) BINAXNOW COVID-19 AG SELT-TESTS. THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE USER WAS ADVISED TO COMMUNICATE WITH HIS HEALTHCARE PROVIDER AND TO SEEK ADDITIONAL CONFIRMATORY TESTING. NO CONSUMER IMPACT/ OUTCOME OCCURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170796 BINAX NOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 171946 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male