BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18774976 · Received February 25, 2024

    Report

    Report Number
    1221359-2024-00218
    Event Type
    Malfunction
    Date Received
    February 25, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 14, 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

    FDA UDI ¿ (B)(4). PER PRODUCT INSERT, TEST RESULTS SHOULD BE READ BETWEEN 15-30 MINUTES. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    FDA UDI ¿ (B)(4). PER PRODUCT INSERT, TEST RESULTS SHOULD BE READ BETWEEN 15-30 MINUTES. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225421 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 225421 AND TEST BASE PART NUMBER 195-430WJR / LOT 222082. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225421 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER THEY COULD POSSIBLY BE RELATED TO SELF-TEST USER PERFORMANCE, RESULT INTERPRETATION OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS BETWEEN THE 15-30 MINUTES READ WINDOW WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. THE TEST RESULT AT 15 MINUTES WAS NEGATIVE. THE TEST RESULT AT 17 MINUTES (TWO MINUTES LATER WITH THE SAME TEST) WAS POSITIVE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS BETWEEN THE 15-30 MINUTES READ WINDOW WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. THE TEST RESULT AT 15 MINUTES WAS NEGATIVE. THE TEST RESULT AT 17 MINUTES (TWO MINUTES LATER WITH THE SAME TEST) WAS POSITIVE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67295 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225421 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female