BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16175555 · Received January 16, 2023

    Report

    Report Number
    1221359-2023-00098
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 28, 2023
    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

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE DEVICE, DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 212528 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 212528 AND DEVICE PART NUMBER 195-430H / LOT 209977. 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 212528 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. D4-EXPIRATION DATE H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE NEGATIVE RESULT WITH THE BINAX NOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED USING A RAPID NAAT TEST SARS COV-2, GENERATING A POSITIVE RESULT ON THE SAME DAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE NEGATIVE RESULT WITH THE BINAX NOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED USING A RAPID NAAT TEST SARS COV-2, GENERATING A POSITIVE RESULT ON THE SAME DAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657107 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212528 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female