BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12369008 · Received August 26, 2021

    Report

    Report Number
    1221359-2021-02392
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 2, 2021
    Report Date
    March 15, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    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 153551 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 153551 AND TEST BASE PART NUMBER 195-430H / LOT 149078. 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 153551 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THAT THE CUSTOMER DID NOT FOLLOW INSTRUCTIONS BY OPENING THE TEST CARD TO READ THE RESULTS, THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, 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 POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A TESTED NASAL KITTED SWAB. THE CUSTOMER TOOK A TEST LAST WEEK WITH BINAXNOW¿ COVID-19 ANTIGEN SELF TEST AND TESTED POSITIVE. THE CUSTOMER REPORTED A RED FAINT DOT ON THE TEST STRIP INSIDE. THE CUSTOMER REALIZED NOW THAT IT WASN`T AN ISSUE WITH THE KIT AT ALL. HE INITIALLY THOUGHT HE WAS SUPPOSED TO OPEN THE CARD AFTER THE 15 MINUTES TO FIND HIS RESULTS INSIDE; WHICH HE WAS ALSO DOING WITH THE PREVIOUS TESTS. HE RETESTED AGAIN AND FOLLOWED THE EXACT STEPS THIS TIME AND RECEIVED A NEGATIVE RESULTS AND NO PINK DOT. PCR CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN SAMPLE AND ON (B)(6) 2021 RECEIVED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT HE WAS CONFUSED ABOUT THE DIFFERENCES BETWEEN A MOLECULAR TEST AND ANTIGEN TEST. THE CUSTOMER ALSO MENTIONED HE HAS HAD COVID TWICE BEFORE. ONCE WAS IN EARLY 2020 AND AGAIN THIS YEAR DURING FEBRUARY- MARCH. THE CUSTOMER SAID HE HAD SYMPTOMS THAT LASTED 25 DAYS BUT HAD SUBSIDED SINCE LAST FRIDAY. SOME OF THOSE SYMPTOMS INCLUDE SHORTNESS OF BREATH, LOSS OF SMELL AND TASTE, AND HAD LOST HEARING IN HIS LEFT EAR DURING A PREVIOUS COVID INFECTION. THE CUSTOMER IS STILL NOT SURE WHETHER IT WAS FROM THAT OR IF IT IS HEREDITARY. THE CUSTOMER REPORTED HE RECEIVED THE PFIZER VACCINE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268018 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153551 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male