BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 20747360 · Received November 21, 2024

    Report

    Report Number
    1221359-2024-00679
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 13, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000905495 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 0000905495 AND DEVICE PART NUMBER 195-430WL/LOT 905495. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 905495 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT IS TWO (2) OF 2 (TWO). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE WITH AN UNKNOWN BRAND USING AN UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED EXPERIENCING SYMPTOMS SUCH AS NASAL CONGESTION, FATIGUE, AND COLD SYMPTOMS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT IS TWO (2) OF 2 (TWO). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. IN THE WEEK PRIOR (DATE UNKNOWN) TO THE NEGATIVE RESULT, THE CONSUMER TESTED POSITIVE WITH AN UNKNOWN BRAND USING AN UNKNOWN SAMPLE TYPE. THE CONSUMER REPORTED EXPERIENCING SYMPTOMS SUCH AS NASAL CONGESTION, FATIGUE, AND COLD SYMPTOMS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458197 BINAXNOW COVID-19 AG SELF TEST 2CT LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000905495 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female