BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 10CT

    MDR report key: 18507942 · Received January 12, 2024

    Report

    Report Number
    1221359-2024-00055
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 24, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011118
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4-UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 235458 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 195-170/ LOT: 235458, TEST BASE PART NUMBER 195-430WL/ LOTS: 227263A, 227263B, AND 227263C. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 235458 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4-UDI: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WAS PERFORMED THREE (3) TIMES ON THE SAME DAY, EACH GENERATING A NEGATIVE RESULT. THREE (3) ADDITIONAL TESTS WERE PERFORMED ON THE SAME DAY USING AN INTELISWAB RAPID ANTIGEN TEST, AN ACCESS BIO RAPID ANTIGEN TEST, AND A LUCIRA RAPID ANTIGEN TEST, ALL GENERATING NEGATING RESULTS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WAS PERFORMED THREE (3) TIMES ON THE SAME DAY, EACH GENERATING A NEGATIVE RESULT. THREE (3) ADDITIONAL TESTS WERE PERFORMED ON THE SAME DAY USING AN INTELISWAB RAPID ANTIGEN TEST, AN ACCESS BIO RAPID ANTIGEN TEST, AND A LUCIRA RAPID ANTIGEN TEST, ALL GENERATING NEGATING RESULTS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817543 BINAXNOW COVID-19 AG SELF TEST 10CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 235458 00811877011118

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female