BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15243796 · Received August 17, 2022

    Report

    Report Number
    1221359-2022-04306
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 17, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INITIAL REPORT AND THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 201430 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 201430 AND DEVICE PART NUMBER 195-430H / LOT 196026. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. PLEASE SEE RELATED MFR REPORT NUMBERS: 1221359-2022-04299 AND 1221359-2022-04303.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE NEGATIVE RESULT USING BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON AN (B)(6) 2022 WITH A NASAL SWAB. THIS REPORT IS FOR TEST SIX (6) OF SIX (6). THE CONSUMER REPORTED FEELING SYMPTOMATIC SO THEY WENT TO THE HOSPITAL AND TESTED POSITIVE WITH AN UNKNOWN TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011607 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 201430 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female