BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12352171 · Received August 22, 2021

    Report

    Report Number
    1221359-2021-02361
    Event Type
    Malfunction
    Date Received
    August 22, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 195-160/ LOT 152369 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 190-430 WL/ LOT 148095. TEST BASE PART NUMBER 190-100J / LOT 152369 . 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 152369 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW (BRR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. 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 OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCED MFR. REPORT #1221359-2021-02356.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST ON (B)(6) 2021 ON A NASAL KITTED SWAB. THE REPORTED THAT SHE OPENED THE PACKAGE FIRST AND THEN WASHED HER HANDS AND THEN BEGAN TAKING THE CARDS OUT TO BEGIN TESTING. THE CUSTOMER STATED SHE THE SWAB WAS NOT TOUCHED THE CUSTOMER REPORTED THAT SHE PERFORMED THE TEST ON BOTH OF HER DAUGHTER AND RECEIVED POSITIVES ON BOTH. A PINK CONTROL LINE AND A PINK FAINT SAMPLE LINE WERE OBSERVED. AFTER RECEIVING THE RESULTS THE CUSTOMER TOOK BOTH OF HER DAUGHTERS TO HER DOCTOR AND PCR TEST WERE GIVEN AND CAME BACK NEGATIVE. THE CUSTOMER REPORTED HER DAUGHTER BEGAN EXPERIENCING A MINOR FLUE AND FEVER SYMPTOMS. 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
    1249346 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 152369

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female