BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16312774 · Received February 7, 2023

    Report

    Report Number
    1221359-2023-00232
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 23, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE CORRECTED FIELD FOR CORRECTIONS: A1 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 212458 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 212458 AND DEVICE PART NUMBER 195-430H / LOT 209876. 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 214751 SHOWED THAT THE COMPLAINT RATE IS 0.000316%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. OTHER - DEVICE NOT RETURNED; SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE EVALUATED BY MFR: DEVICE NOT RETURNED; SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF TEST USING KITTED SWABS ON VARIOUS DATES. THIS MFR REPORT ADDRESSES TEST RESULT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON (B)(6) 2023. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2023 GENERATING POSITIVE RESULTS. THE CONSUMER STATED THAT NO MEDICAL TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF TEST USING KITTED SWABS ON VARIOUS DATES. THIS MFR REPORT ADDRESSES TEST RESULT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON (B)(6) 2023. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2023 GENERATING POSITIVE RESULTS. THE CONSUMER STATED THAT NO MEDICAL TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317215 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212458 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female