BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15363202 · Received September 6, 2022

    Report

    Report Number
    1221359-2022-04405
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 14, 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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: TESTED THE BINAXNOW COVID-19 AG CARD RETAIN KIT LOT 185599 WITH COVID-19 LOD AND BLANK PATIENT SWABS. ALL TESTS WERE RUN IN TRIPLICATE, WERE VALID, AND PERFORMED AS EXPECTED. NO CONFLICTING RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-160 / LOT 185599 AND DEVICE PART NUMBER 195-430H / LOT 181859. 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). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN LABEL CLAIMS. NO FURTHER ACTION IS REQUIRED. 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). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN LABEL CLAIMS. NO FURTHER ACTION IS REQUIRED. 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, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST. THE FIRST TEST GENERATED A POSITIVE RESULT AND THE REPEAT TEST GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831350 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 185599 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown