BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 20858917 · Received December 5, 2024

    Report

    Report Number
    1221359-2024-00704
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    January 1, 2022
    Report Date
    January 13, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. CORRECTIONS: B3 - DATE OF EVENT NULL: FROM NI TO NONE SELECTED. D8 - WAS DEVICE SERVICED BY THIRD PARTY?: FROM NO TO NA. H6 - ADVERSE EVENT PROBLEM - HEALTH EFFECT - IMPACT CODE: FROM F26 TO F24. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 / LOT 207009 AND DEVICE PART NUMBER 195-430H / LOT 202765. 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 207009 SHOWED THAT THE COMPLAINT RATE IS (B)(4). RETAINED TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE PRODUCT BEING EXPIRED AT THE TIME OF THE COMPLAINT. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON UNKNOWN DATES DURING THE MONTH OF JANUARY 2022. THIS MANUFACTURER'S REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING (UNKNOWN BRAND) WAS PERFORMED ON THE SAME DAY AT THE DOCTOR'S OFFICE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING SORE THROAT, FEVER, HEADACHE, EAR PAIN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON UNKNOWN DATES DURING THE MONTH OF (B)(6) 2022. THIS MANUFACTURER'S REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST. ADDITIONAL TESTING (UNKNOWN BRAND) WAS PERFORMED ON THE SAME DAY AT THE DOCTOR'S OFFICE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING SORE THROAT, FEVER, HEADACHE, EAR PAIN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209452 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 207009 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female