BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 12356026 · Received August 23, 2021

    Report

    Report Number
    1221359-2021-02368
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Report Date
    November 29, 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 153551 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 153551 , TEST BASE PART NUMBER 195-430H / LOT 149078 . 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 153551 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. REF MFR REPORTS: 1221359-2021-02369.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR REPORT: 1221359-2021-02369.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED BEHALF OF HER DAUGHTER AND MOTHER TWO UNCONFIRMED FALSE NEGATIVE RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST. THIS MFR. REPORT ADDRESSES PATIENT ONE OF TWO. THE CONSUMER REPORTED BEHALF OF HER DAUGHTER (USER) A UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST. THE CONSUMER CONFIRMED THAT HER DAUGHTER WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252752 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 153551 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female