BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16565294 · Received March 17, 2023

    Report

    Report Number
    1221359-2023-00513
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 17, 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

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225209 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 225209 AND DEVICE PART NUMBER 195-430H / LOT 220866. 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 225209 SHOWED THAT THE COMPLAINT RATE IS (B)(4) 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.B5: UPDATED BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED DATE TO (B)(6) 2023. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED USING KITTED SWAB WITH NASAL SAMPLE ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES RESULT ONE (1) OR THREE (3) AND LOT NUMBER 225209 (QUANTITY 2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING VIA PCR (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. ADDITIONALLY, TESTING WITH ID NOW COVID-19 ASSAY WAS PERFORMED ON (B)(6) 2023 GENERATED A POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED USING KITTED SWAB WITH NASAL SAMPLE ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES RESULT ONE (1) OR THREE (3) AND LOT NUMBER 225209 (B)(4). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. CONFIRMATION TESTING VIA PCR (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. ADDITIONALLY, TESTING WITH ID NOW COVID-19 ASSAY WAS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023 GENERATED A POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664823 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225209 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown