BEUDAMED
    FDA Adverse Event Death Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18237639 · Received November 30, 2023

    Report

    Report Number
    1221359-2023-01690
    Event Type
    Death
    Date Received
    November 30, 2023
    Date of Event
    January 1, 2023
    Report Date
    November 30, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B2: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT DATE OF DEATH WAS NOT PROVIDED. B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT DATE OF EVENT WAS NOT PROVIDED. THE INVESTIGATION OF THE CONSUMER'S COMPLAINT INCLUDED A COMPLAINT TREND ANALYSIS. THERE WAS NO LOT NUMBER INFORMATION PROVIDED AT THE TIME THE INCIDENT OCCURRED TO SUPPORT FURTHER INVESTIGATION ACTIVITIES. BASED ON THE INFORMATION AVAILABLE, A BINAXNOW COVID-19 AG SELF TEST PRODUCT DEFICIENCY WAS NOT IDENTIFIED. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT AN INDIVIDUAL (RELATIONSHIP TO REPORTER UNKNOWN) TESTED NEGATIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT ON AN UNKNOWN DATE. THE CONSUMER INDICATED THAT THE INDIVIDUAL PASSED AWAY THE FOLLOWING DAY DUE TO MENINGITIS. THE CONSUMER INFERRED THAT THE NEGATIVE COVID TEST MAY HAVE CONTRIBUTED TO THE INDIVIDUAL'S DEATH BECAUSE "HER MOTHER WAS TOO WORRIED ABOUT COVID AND NOT ANYTHING ELSE". THERE WAS NO ADDITIONAL COVID TESTING PERFORMED AND NO INCONSISTENCY BETWEEN THE COVID NEGATIVE RESULT AND THE CAUSE OF DEATH. WHILE THERE WAS NO INDICATION THAT THE NEGATIVE BINAXNOW COVID-19 ANTIGEN SELF-TEST RESULT WAS INACCURATE, THERE IS A POSSIBILITY THE BINAXNOW COVID-19 ANTIGEN SELF-TEST RESULT MAY HAVE CONTRIBUTED TO THE INDIVIDUAL'S MOTHER DECISION NOT TO SEEK FURTHER TESTING OR DIAGNOSIS OF THE INDIVIDUAL'S HEALTH CONDITION. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884071 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death