BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15882512 · Received November 29, 2022

    Report

    Report Number
    1221359-2022-10198
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 10, 2022
    Report Date
    February 2, 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 IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 210248 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 NUMBER195-160/ LOT 210248 AND DEVICE PART NUMBER 195-430H / LOT 204649. 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 210248 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 210248 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.D4 (EXP. DATE) AND E3 (OCCUPATION) H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE DEVICE.

    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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONSUMER PERFORMED BINAXNOW COVID-19 ANTIGEN SELF-TEST TWICE, FIRST TEST YIELDING NEGATIVE RESULT AND SECOND TEST YIELDING POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONSUMER PERFORMED BINAXNOW COVID-19 ANTIGEN SELF-TEST TWICE, FIRST TEST YIELDING NEGATIVE RESULT AND SECOND TEST YIELDING POSITIVE RESULT. 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
    403191 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 210248 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown