BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12518835 · Received September 23, 2021

    Report

    Report Number
    1221359-2021-02782
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    August 25, 2021
    Report Date
    April 18, 2022
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1, G4 (PMA/510(K)). INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 158187 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: 158187, TEST BASE PART NUMBER 195-430H / LOT: 154690. 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 148545 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 OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON AN UNKNOWN SAMPLE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT TWO DAYS PRIOR TO THE FIRST TEST ON (B)(6) 2021 THE CUSTOMER REPORTED TAKING A PCR TEST AND OBTAINED POSITIVE RESULTS(CT VALUES NOT PROVIDED). THE CUSTOMER REPORTED THAT THE FIRST TEST SHOWED A HALFWAY PINK AND HALFWAY DARK PINK UNDER CONTROL LINE WITH NO COLOR UNDER THE SAMPLE LINE. THE CONSUMER 'S HUSBAND TOOK THE SECOND BINAXNOW¿ COVID-19 ANTIGEN SELF TEST WITH NO ISSUE AND SHOWED A PINK CONTROL LINE AND NO COLOR UNDER SAMPLE LINE WHICH WAS DETERMINED AS A NEGATIV RESULT. THE CUSTOMER WANTED TO KNOW IF SHE WAS NEGATIVE AND DECIDED TO TRY THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417846 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 158187 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female