BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16683737 · Received April 5, 2023

    Report

    Report Number
    1221359-2023-00580
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 26, 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

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211546 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 211546 AND DEVICE PART NUMBER 195-430H / LOT 207896. 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 211546 SHOWED THAT THE COMPLAINT RATE IS 0.000596%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR MULTIPLE TESTS PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). REPEAT TESTING WAS PERFORMED ON THE SAME DAY USING THE BINAXNOW COVID-19 ANTIGEN SELF-TEST WHICH PRODUCED A POSITIVE RESULT. NO PCR WAS REPORTED TO HAVE BEEN PERFORMED. CONSUMER INDICATED THAT THEY WERE SYMPTOMATIC AND DIAGNOSED WITH COVID-19. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR MULTIPLE TESTS PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). REPEAT TESTING WAS PERFORMED ON THE SAME DAY USING THE BINAXNOW COVID-19 ANTIGEN SELF-TEST WHICH PRODUCED A POSITIVE RESULT. NO PCR WAS REPORTED TO HAVE BEEN PERFORMED. CONSUMER INDICATED THAT THEY WERE SYMPTOMATIC AND DIAGNOSED WITH COVID-19. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008405 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211546 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female