BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13398991 · Received January 31, 2022

    Report

    Report Number
    1221359-2022-00666
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 2, 2022
    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

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 173318 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 KIT PART NUMBER 195-160/LOT 173318 AND DEVICE PART NUMBER 195-430WL / LOT 170717. 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 173318 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST OTC, 2 TEST PACK USING UNKNOWN SAMPLE TYPES. THE FIRST ANTIGEN SELF TEST WAS PERFORMED ON (B)(6) 2022 AT 7:00PM WHICH GENERATED A POSITIVE RESULT. THE SECOND ANTIGEN SELF TEST WAS PERFORMED ON (B)(6) 2022 AT 12:00PM WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER STATED SHE WAS SYMPTOMATIC EXPERIENCING, FEVER, BODY ACHES AND SORE THROAT. TECHNICAL SERVICES (TS) ADVISED THE CONSUMER TO CONTACT THEIR HEALTHCARE PROVIDER FOR FURTHER GUIDANCE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751227 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 173318 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown