BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16627327 · Received March 28, 2023

    Report

    Report Number
    1221359-2023-00553
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 20, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 210018 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 210018 AND DEVICE PART NUMBER 195-430/ LOT 207396. 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 210018 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED USING AN UNKNOWN TESTING KIT AND UNKNOWN SAMPLE TYPE LATER THE SAME DAY (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER STATED THAT THE ONLY SYMPTOMS SHE WAS EXPERIENCING AT THE TIME OF TESTING WERE ALLERGY RELATED AND NOTED THAT SHE HAD TAKEN NEILMED NASAL SPRAY "HOURS BEFORE PERFORMING HER TEST" TO HELP WITH THESE SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED USING AN UNKNOWN TESTING KIT AND UNKNOWN SAMPLE TYPE LATER THE SAME DAY ((B)(6) 2023) AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER STATED THAT THE ONLY SYMPTOMS SHE WAS EXPERIENCING AT THE TIME OF TESTING WERE ALLERGY RELATED AND NOTED THAT SHE HAD TAKEN NEILMED NASAL SPRAY "HOURS BEFORE PERFORMING HER TEST" TO HELP WITH THESE SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 210018 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female