BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 20297270 · Received September 24, 2024

    Report

    Report Number
    1221359-2024-00619
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 10, 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

    THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5: UPDATED SUMMARY TO IMPROVE CLARITY. H6: CHANGED CODE F26 TO F24. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 854819A 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 854819A, AND DEVICE PART NUMBER 195-430WJR / LOT 854819A. 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 854819 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 854819 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS, BOTH PERFORMED ON (B)(6) 2024. THE CUSTOMER TESTED WITH THEIR FIRST TEST AND RECEIVED A POSITIVE RESULT, THOUGH THE CUSTOMER DEVIATED FROM THE PROCEDURE. THE CUSTOMER RE-TESTED WITH THE CORRECT PROCEDURE AND RECEIVED A NEGATIVE RESULT. THE CUSTOMER EXPERIENCES SYMPTOMS OF FATIGUE AND A COUGH. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS, BOTH PERFORMED ON (B)(6) 2024. THE CUSTOMER TESTED WITH THEIR FIRST TEST AND RECEIVED A POSITIVE RESULT. THE CUSTOMER THEN TESTED WITH A SECOND BINAXNOW COVID-19 AG SELF TEST AND RECEIVED A NEGATIVE RESULT. THE CUSTOMER EXPERIENCES SYMPTOMS OF FATIGUE AND A COUGH. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198909 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 854819A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male