BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16683579 · Received April 5, 2023

    Report

    Report Number
    1221359-2023-00577
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 25, 2023
    Report Date
    April 5, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 196077 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 KIT PART NUMBER 195-160/ LOT 196077 AND DEVICE PART NUMBER 195-430H/ LOT 191574. 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 196077 SHOWED THAT THE COMPLAINT RATE IS 0.000331%. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 196077 SHOWED THAT THE COMPLAINT RATE IS 0.000331%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR MULTIPLE TESTS PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CONSUMER REPORTED THAT THE TEST GENERATED A POSITIVE RESULT WHEN READ AT THE FIFTEEN (15) MINUTE MARK, BUT THAT THE SAMPLE LINE DISAPPEARED BEFORE THE THIRTY (30) MINUTE MARK. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349518 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 196077 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male