BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 1CT

    MDR report key: 19081192 · Received April 10, 2024

    Report

    Report Number
    1221359-2024-00334
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 26, 2024
    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

    CORRECTED DATA - H4 - DEVICE MFG DATE TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 791938 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 195-140 / LOT 791938, TEST BASE PART NUMBER 195-430WL / LOT 791938. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 791938 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH 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.

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT PERFORMED WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON 29MAR2024 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER PERFORMED AN IHEALTH COVID-19 ANTIGEN RAPID TEST AND AN AZURE ANTIGEN RAPID HOME TEST ON 30MAR2024, BOTH TESTS GENERATED NEGATIVE RESULTS. THE CONSUMER WAS ASYMPTOMATIC ON 29MAR2024 FOR HER POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT PERFORMED WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER PERFORMED AN IHEALTH COVID-19 ANTIGEN RAPID TEST AND AN AZURE ANTIGEN RAPID HOME TEST ON (B)(6) 2024, BOTH TESTS GENERATED NEGATIVE RESULTS. THE CONSUMER WAS ASYMPTOMATIC ON (B)(6) 2024 FOR HER POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419213 BINAXNOW COVID-19 AG SELF TEST 1CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 791938 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female