BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18455874 · Received January 5, 2024

    Report

    Report Number
    1221359-2024-00031
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 23, 2023
    Report Date
    January 17, 2024
    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

    D4: UDI (B)(4).THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 226356 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: 226356, TEST BASE PART NUMBER 195-430H/ LOT: 223453. 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 226356 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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT USING BINAXNOW COVID-19 AG SELF TEST ON (B)(6)2023 WITH AN UNKNOWN SAMPLE. CONSUMER STATES THAT THEY HAD JUST TAKEN A SARS-COV-2 COVID-19 ANTIGEN TEST 30 MINUTES PRIOR AT THE URGENT CARE, GENERATING A POSITIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT USING BINAXNOW COVID-19 AG SELF TEST ON 23DEC2023. CONSUMER STATES THAT THEY HAD JUST TAKEN A SARS-COV-2 COVID-19 ANTIGEN TEST 30 MINUTES PRIOR AT AN URGENT CARE, GENERATING A POSITIVE RESULT. THE CONSUMER RECEIVED TREATMENT FROM URGENT CARE BASED ON THE POSITIVE RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569039 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 226356 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male