BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 12741197 · Received November 2, 2021

    Report

    Report Number
    1221359-2021-03384
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 4, 2021
    Report Date
    April 14, 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 160130 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 195-160/195-260 / LOT 160130 AND TEST BASE PART NUMBER 195-430WL / LOT 153061. 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 160130 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 SELF-TEST USER PERFORMANCE, 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. MFR REF REPORT: 1221359-2021-03385.

    Description of Event or Problem · 1

    THE CONSUMER BEHALF OF HER DAUGHTER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST FOR A PATIENT PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES LOT 160130 AND IS 1 OF 2. THE CONSUMER REPORTED 2 FALSE POSITIVE RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. PCR CONFIRMATION TESTING (X2) WERE PERFORMED ON (B)(6) 2021, BOTH GENERATED NEGATIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY IN THE PATIENT'S TREATMENT, HOWEVER CONSUMER MENTIONED THAT HER DAUGHTER WILL HAD AN APPOINTMENT TO HER PEDIATRICIAN FOR MEDICAL PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638102 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 160130 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female