BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13453508 · Received February 4, 2022

    Report

    Report Number
    1221359-2022-00734
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 5, 2022
    Report Date
    June 8, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. RELATED REPORT: 1221359-2022-00733.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE THE UPDATES: A3, B4, D4, G3,G6,H2, H4, H6 AND H10. TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 174281 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 174281 AND DEVICE PART NUMBER 195-430H / LOT 170398. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 174281 SHOWED THAT THE COMPLAINT RATE IS 0.001%. 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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST OTC,2 TEST PACK PERFORMED ON (B)(6) 2022 USING NASAL SWAB SAMPLES. CONFIRMATION PCR TESTING WAS PERFORMED AT AXIS HEALTHCARE THE SAME DAY ON (B)(6) 2022, USING AN UNSPECIFIED SAMPLE TYPE, WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER REPORTED THAT HER DAUGHTER WAS SYMPTOMATIC PRESENTING A SLIGHT HEADACHE. THE CONSUMER NOTIFIED THE DAUGHTERS SCHOOL AND QUARANTINED HER DUE TO THE INITIAL ANTIGEN SELF TEST RESULTS. NO FURTHER ADVERSE EFFECTS WERE REPORTED. THIS MANUFACTURER REPORT ADDRESSES FALSE POSITIVE RESULT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649433 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 174281

    Patients

    Seq Age Sex Outcome Treatment
    1 Female