BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13362368 · Received January 26, 2022

    Report

    Report Number
    1221359-2022-00517
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    December 31, 2021
    Report Date
    June 13, 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

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION : D4 CORRECTION : D1, G4, H4 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 160112 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 160112 AND TEST BASE PART NUMBER 195-430H / LOT 150389. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M162291 SHOWED THAT THE COMPLAINT RATE IS 0.0003% AND 0.0003% RESPECTIVELY. 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 SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT SECTION B3 AND B5. THE "DATE OF EVENTS" WAS PREVIOUSLY REPORTED INCORRECTLY AS (31DEC2022 AND HAS BEEN CORRECTED TO SHOW 31DEC2021. B5. CORRECTION: THE PREVIOUSLY REPORTED EVENT REFERENCED THE "ID NOW COVID-19 ASSAY" AS THE DEVICE USED FOR TESTING IN B5. THE REPORTED EVENT HAS BEEN CORRECTED AND DESCRIBED IN B.5.

    Description of Event or Problem · 0

    THE USER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021 ON AN UNKNOWN SWAB SAMPLE AND GENERATED A POSITIVE RESULT. THE USER REPORTED THAT REPEAT TESTING WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2021 AND OBTAINED A NEGATIVE RESULTS. THE USER MENTIONED A PCR CONFIRMATION TEST WAS SCHEDULED. THE USER MENTIONED THAT HE FOLLOW'S ALL THE PROCEDURE WHEN TAKING THE TEST. THE USER SAID THAT SHE DOESN'T FEEL ANY SYMPTOMS. THE USER CONFIRMED THAT SHE WAS FEELING OKAY. THERE WAS NO TREATMENT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. ALTHOUGH REQUESTED, THE PCR TEST RESULTS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE USER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED 31DEC2021 ON AN UNKNOWN SWAB SAMPLE AND GENERATED A POSITIVE RESULT. THE USER REPORTED THAT REPEAT TESTING WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2021 AND OBTAINED A NEGATIVE RESULTS. THE USER MENTIONED A PCR CONFIRMATION TEST WAS SCHEDULED. THE USER MENTIONED THAT HE FOLLOW'S ALL THE PROCEDURE WHEN TAKING THE TEST. THE USER SAID THAT SHE DOESN'T FEEL ANY SYMPTOMS. THE USER CONFIRMED THAT SHE WAS FEELING OKAY. THERE WAS NO TREATMENT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. ALTHOUGH REQUESTED, THE PCR TEST RESULTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39759 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 160112 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female