BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 15379631 · Received September 8, 2022

    Report

    Report Number
    1221359-2022-04441
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 28, 2022
    Report Date
    September 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

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SEE BELOW FOR LOT INFORMATION BRAND NAME. LOT #: 209368 EXPIRATION DATE: 03SEP2023 UDI #: (B)(4). LOT #: 210193 EXPIRATION DATE: 14SEP2023 UDI #: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 209368 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 209368, TEST BASE PART NUMBER 195-430H / LOT 204678. 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 209368 SHOWED THAT THE COMPLAINT RATE IS (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 210193 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 210193, TEST BASE PART NUMBER 195-430H / LOT 207464. 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 210193 SHOWED THAT THE COMPLAINT RATE 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 SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAX NOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6)2022 WITH TWO DIFFERENT LOT NUMBERS (209368 AND 210193). THE CONSUMER PERFORMED TWO TESTS. THE FIRST TEST'S RESULTS WERE POSITIVE AND THE SECOND TEST'S RESULTS WERE NEGATIVE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238143 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown