BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 21816561 · Received April 10, 2025

    Report

    Report Number
    1221359-2025-00183
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 12, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011729
    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 000904536A 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 195-180/ LOT 000904536A AND DEVICE PART NUMBER 195-430WL/ LOT 904536. 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 000904536 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 PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025 WITH NASAL SAMPLE. THE CONSUMER INITIALLY TESTED WITH A INTELISWAB TEST ON (B)(6) 2025 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS ASYMPTOMATIC WHEN TESTED NEGATIVE ON (B)(6) 2025 AND CONFIRMED THAT THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025 WITH NASAL SAMPLE. THE CONSUMER INITIALLY TESTED WITH A INTELISWAB TEST ON (B)(6) 2025 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS ASYMPTOMATIC WHEN TESTED NEGATIVE ON (B)(6) 2025 AND CONFIRMED THAT THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415688 BINAXNOW COVID-19 AG SELF TEST 4CT LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000904536A 00811877011729

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female