BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16488038 · Received March 6, 2023

    Report

    Report Number
    1221359-2023-00445
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    November 1, 2022
    Report Date
    May 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

    B3: EVENT DATE IS AN APPROXIMATION. INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 214292 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 214292 AND DEVICE PART NUMBER 195-430WL / LOT 212629. 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 214292 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Additional Manufacturer Narrative · 0

    EVENT DATE IS AN APPROXIMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENT REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWELVE (12) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST ON UNKNOWN DATES PERFORMED BY HIMSELF AND HIS FAMILY MEMBERS BEGINNING DURING THE "HOLIDAY" SEASON OF 2022. THIS REPORT IS FOR RESULT ELEVEN (11) OF TWELVE (12). THREE OF THE FOUR FAMILY MEMBERS WERE TESTED AT URGENT CARE CENTERS (PLATFORM UNKNOWN) ON UNKNOWN DATES AND EACH TIME PRESENTED POSITIVE RESULTS. NO ADDITIONAL INFORMATION INCLUDING OUTCOME OR TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    REPORTED TWELVE (12) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST ON UNKNOWN DATES PERFORMED BY HIMSELF AND HIS FAMILY MEMBERS BEGINNING DURING THE "HOLIDAY" SEASON OF 2022. THIS REPORT IS FOR RESULT ELEVEN (11) OF TWELVE (12). THREE OF THE FOUR FAMILY MEMBERS WERE TESTED AT URGENT CARE CENTERS (PLATFORM UNKNOWN) ON UNKNOWN DATES AND EACH TIME PRESENTED POSITIVE RESULTS. NO ADDITIONAL INFORMATION INCLUDING OUTCOME OR TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549516 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 214292 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female