BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14163696 · Received April 20, 2022

    Report

    Report Number
    1221359-2022-01853
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01852 THROUGH 1221359-2022-01854.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 175659 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 NUMBER195-160 / LOT 175659 , TEST BASE PART NUMBER 195-430WL / LOT 172742.. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 175659 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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. REFERENCE MFR. REPORTS: 1221359-2022-01852 THROUGH 1221359-2022-01854.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE (3) UNCONFIRMED FALSE NEGATIVE RESULTS, PERFORMED ON THE 3RD, 5TH, AND 7TH DAY OF ILLNESS, WITH THE SAME LOT OF BINAXNOW COVID-19 SELF-TEST. THIS REPORT REFERENCES TESTING ON THE 5TH DAY OF ILLNESS WITH THE PATIENT "FEELING SICK". THE PATIENT HAD BEEN EXPOSED TO PEOPLE THAT WERE CONFIRMED POSITIVE WITH COVID.ANOTHER BRAND TEST WAS PERFORMED ON THE 10TH DAY OF ILLNESS AND GENERATED A POSITIVE RESULT.THE PATIENT RECEIVED MODERNA VACCINE ON (B)(6) 2021 ,AND BOOSTER SHOT ON (B)(6) 2022. CONFIRMATION TESTING WAS NOT PERFORMED.NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. THIS REPORT ADDRESSES TEST TWO (2) OF THREE (3) TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227117 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 175659 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown