BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 21192988 · Received January 20, 2025

    Report

    Report Number
    1221359-2025-00016
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 10, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE DATE PROVIDED IS AN ESTIMATION AS THE EXACT DATE OF EVENT COULD NOT BE OBTAINED. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE DATE PROVIDED IS AN ESTIMATION AS THE EXACT DATE OF EVENT COULD NOT BE OBTAINED. CORRECTIONS: A2 - DOB NULL: CHANGED FROM NI TO ASKU TO ALIGN WITH THE COMPLAINT DETAILS. A2 - AGE UNITS (PATIENT): CHANGED FROM NI TO ASKU TO ALIGN WITH THE COMPLAINT DETAILS. A3A - SEX: CHANGED FROM NONE SELECTED TO FEMALE TO ALIGN WITH THE COMPLAINT DETAILS. A3B - GENDER: CHANGED FROM NONE SELECTED TO CISGENDER WOMAN/GIRL (GENDER CORRESPONDS WITH BIRTH SEX) TO ALIGN WITH THE COMPLAINT DETAILS. A4 - WEIGHT UNITS (PATIENT): CHANGED FROM NI TO ASKU TO ALIGN WITH THE COMPLAINT DETAILS. A5 - ETHNICITY: CHANGED FROM NI TO ASKU TO ALIGN WITH THE COMPLAINT DETAILS. A6 - RACE: CHANGED FROM NI TO ASKU TO ALIGN WITH THE COMPLAINT DETAILS. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS TAKEN AT AN UNKNOWN DATE. THIS REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH A BINAXNOW COVID-19 AG SELF TEST TAKEN ON AN UNKNOWN DATE. THE CONSUMER MENTIONED A SYMPTOM OF LOSS OF TASTE. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, IS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH TWO (2) BINAXNOW COVID-19 AG SELF TESTS TAKEN AT AN UNKNOWN DATE. THIS REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH A BINAXNOW COVID-19 AG SELF TEST TAKEN ON AN UNKNOWN DATE. THE CONSUMER MENTIONED A SYMPTOM OF LOSS OF TASTE. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439646 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female