BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST OTC

    MDR report key: 14596719 · Received June 3, 2022

    Report

    Report Number
    1221359-2022-02816
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 8, 2022
    Report Date
    June 3, 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

    INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4). ON RETAINED KIT LOT 179175 WITH INTERNAL LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X3 DEVICES AND NEGATIVE (BLANK) SWABS X3 DEVICES. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 / LOT 179175 AND DEVICE PART NUMBER 195-430H / LOT 173044. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO FALSE POSITIVE 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 THE STATEMENTS MADE WITHIN THE PACKAGE INSERT STATEMENTS. ABBOTT DIAGNOSTICS (B)(4) 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 CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2022 WITH A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON (B)(6)2022 AND GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS PERFORMED WITH AN UNKNOWN RAPID TEST AND GENERATED A NEGATIVE RESULT. THE CONSUMER STATED THAT HE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800535 BINAXNOW COVID-19 ANTIGEN SELF TEST OTC LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 179175 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male