BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 21264672 · Received January 29, 2025

    Report

    Report Number
    1221359-2025-00025
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 21, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    UDI-DI
    00811877011729
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D2B - PROCODE. G4 - PMA/510(K). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000905512A 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 195-180/ LOT 000905512A, TEST BASE PART NUMBER 195-430WJR/ LOT 905512. 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 000905512 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 THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. A PREVIOUS TEST (ACCESS BIO CARE START) WAS PERFORMED ON (B)(6) 2025 AND GENERATED POSITIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING DETAILS ABOUT THE TREATMENT AND THE OUTCOME.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. A PREVIOUS TEST (ACCESS BIO CARE START) WAS PERFORMED ON (B)(6) 2025 AND GENERATED POSITIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING DETAILS ABOUT THE TREATMENT AND THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791723 BINAXNOW COVID-19 AG SELF TEST 4CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000905512A 00811877011729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female