BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16554537 · Received March 16, 2023

    Report

    Report Number
    1221359-2023-00511
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 8, 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 INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 212814 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 212814 AND DEVICE PART NUMBER 195-430WL/ LOT 210014. 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 212814 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. ABBOTT DIAGNOSTICS SCARBOROUGH WILL CONTINUE TO MONITOR AND TREND FOR THIS REPORTED ISSUE AS PART OF OUR ONGOING POST MARKET SURVEILLANCE. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023.THE CONSUMER RECEIVED A NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. A CONFIRMATORY TEST (PCR) WAS PERFORMED AT TEST CENTER ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS EXPOSED TO SOMEONE WITH COVID-19 ON (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON 14MAR2023.THE CONSUMER RECEIVED A NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON 11MAR2023. A CONFIRMATORY TEST (PCR) WAS PERFORMED AT TEST CENTER ON 10MAR2023 AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS EXPOSED TO SOMEONE WITH COVID-19 ON 08MAR2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496550 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212814 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female