BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17410863 · Received July 27, 2023

    Report

    Report Number
    1221359-2023-01293
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 22, 2023
    Report Date
    August 11, 2023
    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 REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 205256 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 205256, TEST BASE PART NUMBER 195-430H/ LOT 200544. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND/OR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 205256 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A BOSON ANTIGEN SELF-TEST TEST ON THE SAME DAY AND GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. 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 WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A BOSON ANTIGEN SELF-TEST TEST ON THE SAME DAY AND GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325580 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 205256 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female