BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12257097 · Received July 31, 2021

    Report

    Report Number
    1221359-2021-02144
    Event Type
    Malfunction
    Date Received
    July 31, 2021
    Date of Event
    July 6, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 153495 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 1195-430H / LOT 149466 . TEST BASE PART NUMBER 195-160 / LOT 153495. 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 153495 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 · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A TESTED NASAL SWAB. THE CONSUMER REPORTED THAT THE CONTROL LINE SHOWED A FAINT PINK COLOR AND A DARK PURPLE COLOR ON THE SAMPLE LINE. REPEAT TESTING WAS NOT PERFORMED. THE CONSUMER REPORTED THAT HE HAD BEEN VACCINATED ON FRIDAY (B)(6) 2021 AND WAS EXPERIENCING SOME CHILLS TODAY AND FEVER, NOT FEELING GOOD SO FAR. TECHNICAL SERVICES ADVISED THE CONSUMER THAT A POSITIVE TEST RESULT MEANS IT IS VERY LIKELY YOU HAVE COVID-19 AND IT IS IMPORTANT TO BE UNDER THE CARE OF YOUR HEALTHCARE PROVIDER. IT IS ALSO LIKELY THAT YOU MAY BE PLACED IN ISOLATION TO AVOID SPREADING THE VIRUS TO OTHERS. THERE IS A VERY SMALL CHANCE THAT THIS TEST CAN GIVE A POSITIVE RESULT THAT IS WRONG (A FALSE POSITIVE RESULT). IF YOU TEST POSITIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST, YOU SHOULD SELF-ISOLATE AND SEEK FOLLOW-UP CARE WITH YOUR HEALTHCARE PROVIDER. YOUR HEALTHCARE PROVIDER WILL WORK WITH YOU TO DETERMINE HOW BEST TO CARE FOR YOU BASED ON YOUR TEST RESULT(S) ALONG WITH YOUR MEDICAL HISTORY, AND YOUR SYMPTOMS. NO ADDITIONAL CONSUMER INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154269 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153495 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown