BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12808045 · Received November 12, 2021

    Report

    Report Number
    1221359-2021-03496
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    December 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION. PLEASE SEE UPDATES FIELDS: D1, D3,G1, AND G3.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 160521 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 160521 AND DEVICE PART NUMBER 195-430H / LOT 150417. 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 160521 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, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE INTERPRETATION OF THE RESULT OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE USER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST ON A DIRECT TESTED NASAL KITTED SWAB. THE USER STATES THAT THE INITIAL BINAXNOW TEST PROVIDED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED WITH NEGATIVE RESULTS. THE USER STATES THAT A THIRD TEST WAS PERFORMED WITH AN UNKNOWN TEST TYPE PROVIDING POSITIVE RESULTS. THE PATIENT WAS ADVISED BY PHYSICAL TO QUARANTINE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703953 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCABOROUGH 160521 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female