BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 18956312 · Received March 21, 2024

    Report

    Report Number
    1221359-2024-00297
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227687Y 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 195-000/ LOT 227687Y, TEST BASE PART NUMBER 195-430H/ LOT 223637. 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 227687Y SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE BINAXNOW COVID-19 AG CARD CUSTOMER RETURN KIT LOT 227687Y WAS TESTED USING THE RETURNED KIT COMPONENTS INCLUDING DEVICES, EXTRACTION REAGENT, BLANK PATIENT SWABS, AND IN-HOUSE COVID-19 LOD POSITIVE CONTROL. ALL TESTS WERE RUN IN TRIPLICATE, WERE VALID, AND PERFORMED AS EXPECTED. NO FALSE POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE FALSE RESULTS; HOWEVER, THEY COULD POSSIBLY BE RELATED TO SELF-TEST USER PERFORMANCE OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND WAS NOT ON ANY TREATMENT FOR COVID. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6)2024. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON (B)(6)2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND WAS NOT ON ANY TREATMENT FOR COVID. PATIENTS WERE TRANSFERRED TO A QUARANTINE AREA DUE TO FALSE POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553038 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 227687Y 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown