BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14215495 · Received April 26, 2022

    Report

    Report Number
    1221359-2022-02349
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 26, 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: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT 178291 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 178291 AND DEVICE PART NUMBER 195-430H / LOT 173140. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS XXXXXXXX PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 178291 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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 CUSTOMER REPORTED CONFLCTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASAL KITTED SWAB. THE USER CONDUCTED THE TEST ON (B)(6) 2022 AND 1 MINUTE AFTER THE 15 MINUTES WAITING PERIOD HE NOTICED 2 PINK LINES APPEARED ON THE RESULT WINDOW. THE USER WAITED FOR ANOTHER 5 MINUTES (WHICH IS STILL ON A VALID READING TIME- A TOTAL OF 6 MINUTES AFTER THE 15 MINUTES WAITING PERIOD), HE NOTED ONLY SEEING A PINK LINE ON THE CONTROL SECTION AND THE LINE ON THE SAMPLE SECTION DISAPPEARED AND A VISIBLE VERTICAL PINK LINE APPEARED ON THE RIGHT EDGE OF THE TEST STRIP. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968800 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 178291 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown