BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID - 19 ANTIGEN SELF TEST

    MDR report key: 12285674 · Received August 5, 2021

    Report

    Report Number
    1221359-2021-02194
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    June 28, 2021
    Report Date
    December 5, 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

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153679 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 -195-263 / LOT 153679. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING RESULTS PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153679 SHOWED THAT THE COMPLAINT RATE IS 0.003%. 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

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS OF THE INTIAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS. C IS UPDATED SO THAT G4 WILL NO LONGER HAVE "COMBINATION PRODUCT" CHECKED.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID - 19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. THE CUSTOMER REPORTED THAT THE PATIENT INITIAL TEST PERFORMED ON (B)(6) 2021 GENERATED POSITIVE RESULTS. THE CUSTOMER STATES THE PATIENTS'S SECOND TEST PERFORMED ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177479 BINAXNOW COVID - 19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCABOROUGH 153679 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown