BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST

    MDR report key: 12221042 · Received July 23, 2021

    Report

    Report Number
    1221359-2021-02104
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    November 22, 2022
    Report Date
    November 23, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153476 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: 153476 , TEST BASE PART NUMBER 195-430H / LOT: 148405. 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 153476 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING WAS NOT PERFORMED. PER THE CONSUMER, THE PATIENT WAS SYMPTOMATIC WITH COLD SYMPTOMS. PATIENT IS FULLY VACCINATED. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116806 BINAXNOW COVID-19 AG SELF TEST LATERFLOW IMMUNOASSAY FOR COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 153476 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown