BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16141268 · Received January 11, 2023

    Report

    Report Number
    1221359-2023-00063
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 6, 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 172637 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 187931 AND DEVICE PART NUMBER 195-430 / LOT 181967. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 187931 BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED 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.

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE DEVICE, DISCARDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE NEGATIVE RESULT WITH THE BINAX NOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED USING AN UNKNOWN PCR PLATFORM ON (B)(6) 2022 AND GENERATED A POSITIVE TEST RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE NEGATIVE RESULT WITH THE BINAX NOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED USING AN UNKNOWN PCR PLATFORM ON (B)(6) 2022 AND GENERATED A POSITIVE TEST RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177643 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 187931 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female