BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16916207 · Received May 11, 2023

    Report

    Report Number
    1221359-2023-01113
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 11, 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

    D4: THE CONSUMER REPORTED TWO LOT NUMBERS 217441 AND 221684 FOR TESTS PERFORMED BETWEEN (B)(6) 2023 AND (B)(6) 2023. CUSTOMER IS UNSURE ON WHAT DAYS THEY WERE USED. INFORMATION FOR LOT NO. 217441. EXPIRATION DATE: 03JUL2024 . INFORMATION FOR LOT NUMBER 221684. EXPIRATION DATE: 26JUL2024. INVESTIGATION RESULTS: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 217441 AND 221684 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 217441 / 221684 AND DEVICE PART NUMBER 195-430H / LOT 214607 / 217982. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 217441 AND 221684 SHOWED THAT THE COMPLAINT RATE IS 0.00179% AND 0.000507% RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH 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 : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED NINE (9) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED BETWEEN (B)(6) 2023 TO (B)(6) 2023. THIS MFR. REPORT ADDRESSES RESULT ONE (1) OF NINE (9). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON (B)(6) 2023. CONFIRMATION TESTING VIA PCR (PLATFORM LUCERA) WAS PERFORMED ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS REPORTEDLY SYMPTOMATIC. THE CONSUMER STATED THAT TREATMENT WAS PRESCRIBED AS A RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817856 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female