BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12278813 · Received August 5, 2021

    Report

    Report Number
    1221359-2021-02207
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 12, 2021
    Report Date
    November 28, 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION : D2, D4, G4 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 155582 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 155582 AND TEST BASE PART NUMBER 195-430H/ LOT 150521. 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 155582 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 THE 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 CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW" COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A NASAL SWAB. THE CONSUMER REPORTED THAT THE FIRST TEST DISPLAYED A PINK COLOR UNDER THE CONTROL LINE AND PINK COLOR UNDER SAMPLE LINE (POSITIVE). THE CUSTOMER REPORTED MULTIPLE VERTICAL LINES THAT WERE A PINK COLOR THAT WAS LOCATED ACROSS EACH LINE, UNDER CONTROL AND SAMPLE LINE. THE CONSUMER REPORTED THAT HE WAS FULLY VACCINATED SINCE (B)(6) (1ST DOSE) AND (B)(6) (2ND DOSE). PCR CONFIRMATION TESTING WAS PERFORMED ON A NASOPHARYNGEAL SWAB AND GENERATED NEGATIVE. THE CONSUMER STATED HE WAS FELT CONGESTED, SNEEZING AND SOME COUGHING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. TECHNICAL SERVICE INFORMED THE CUSTOMER THAT THEIR FIRST TEST RESULT MY INTERPRETATION IS POSITIVE, MEANING IT IS VERY LIKELY THAT YOU HAVE COVID-19 AND IT IS IMPORTANT FOR YOU 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 AND THERE IS A VERY SMALL CHANCE THAT THIS TEST CAN GIVE A POSITIVE RESULT THAT IS WRONG (A FALSE POSITIVE RESULT). IF YOU TESTED 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 HIS MEDICAL HISTORY, AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180777 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 155582 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown