BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 21152320 · Received January 14, 2025

    Report

    Report Number
    1221359-2025-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    January 4, 2025
    Report Date
    January 14, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000904221A 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 000904221A AND DEVICE PART NUMBER 195-430WJR / LOT 904221. 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 000904221 SHOWED THAT THE COMPLAINT RATE IS 0.00105%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, IT COULD POSSIBLY BE RELATED TO SELF-TEST USER PERFORMANCE OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS, BOTH PERFORMED ON (B)(6) 2025. THIS REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH A BINAXNOW COVID-19 AG SELF TEST TAKEN ON 04 JAN 2025. THREE (3) FLOWFLEX COVID-19 ANTIGEN HOME TESTS WERE TAKEN ON (B)(6) 2025, ALL WITH POSITIVE RESULTS. THE CONSUMER MENTIONED HAVING SYMPTOMS OF FEVER, COUGH, STUFFY NOSE, HEADACHE, AND FATIGUE. THERE WAS NO TREATMENT TAKEN, NOR INJURY REPORTED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178301 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000904221A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female