BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 21844272 · Received April 15, 2025

    Report

    Report Number
    1221359-2025-00199
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    UDI-DI
    00811877011408
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. CORRECTION: G4 - PMA/510(K) #. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000905503A 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: 000905503A, TEST BASE PART NUMBER 195-430WL/ LOT: 905503. 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 000905503 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH A NASAL SAMPLE. PREVIOUS TESTING (FLOWFLEXTEST) WAS PERFORMED ON AN UNKNOWN DATE GENERATING A NEGATIVE RESULT. THE CONSUMER STATED THAT THEY WERE EXPERIENCING SYMPTOMS OF LOSS OF SMELL, LUNG CONGESTION, NASAL CONGESTION, FATIGUE, LACK OF APPETITE, HEADACHES, AND CHILLS. THE CONSUMER REPORTED THAT THEIR SENSE OF SMELL RETURNED, HOWEVER, NO ADDITIONAL CONSUMER INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON UNKNOWN DATE WITH A NASAL SAMPLE. PREVIOUS TESTING (FLOWFLEXTEST) WAS PERFORMED ON AN UNKNOWN DATE GENERATING A NEGATIVE RESULT. THE CONSUMER STATED THAT THEY WERE EXPERIENCING SYMPTOMS OF LOSS OF SMELL, LUNG CONGESTION, NASAL CONGESTION, FATIGUE, LACK OF APPETITE, HEADACHES, AND CHILLS. THE CONSUMER REPORTED THAT THEIR SENSE OF SMELL RETURNED, HOWEVER, NO ADDITIONAL CONSUMER INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425391 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000905503A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female