BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16151951 · Received January 12, 2023

    Report

    Report Number
    1221359-2023-00067
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 23, 2022
    Report Date
    February 23, 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 212528 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 212528 AND DEVICE PART NUMBER 195-430H / LOT 209977. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 212528 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ALL TESTS WERE VALID AND PERFORMED AS EXPECTED AND THE CUSTOMER COMPLAINT WAS NOT REPLICATED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT ON (B)(6) 2022 WITH BINAXNOW COVID-19 AG SELF-TEST. THE CONSUMER RECEIVED A POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022, AND A NEGATIVE RESULT ON UNKNOWN BRAND ON (B)(6) 2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT ON (B)(6) 2022 WITH BINAXNOW COVID-19 AG SELF-TEST. THE CONSUMER RECEIVED A POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022, AND A NEGATIVE RESULT ON UNKNOWN BRAND ON (B)(6) 2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075345 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212528 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female