BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17261581 · Received July 5, 2023

    Report

    Report Number
    1221359-2023-01259
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 25, 2023
    Report Date
    July 12, 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. DEVICE DISCARDED; SINGLE-USE DEVICE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 214751 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 214751, TEST BASE PART NUMBER 195-430H/ LOT 212735. 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 214751 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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 : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE TESTS WERE PERFORMED WITH THE KIT SWAB ON A NASAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM UNKNOWN) AND ADDITIONALLY WITH QUICKVUE ANTIGEN TEST PERFORMED ON (B)(6) 2023, GENERATING NEGATIVE RESULTS RESPECTIVELY. THE CONSUMER REPORTEDLY WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE TESTS WERE PERFORMED WITH THE KIT SWAB ON A NASAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM UNKNOWN) AND ADDITIONALLY WITH QUICKVIEW ANTIGEN TEST PERFORMED ON (B)(6) 2023, GENERATING NEGATIVE RESULTS RESPECTIVELY. THE CONSUMER REPORTEDLY WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990690 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 214751 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female