BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 19751832 · Received July 16, 2024

    Report

    Report Number
    1221359-2024-00494
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 220606 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: 220606, TEST BASE PART NUMBER 195-430WJR/ LOT: 217803. 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 220606 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

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ONCE MORE ON (B)(6) 2024, TWICE ON (B)(6) 2024, AND TWICE ON (B)(6) 2024 WHICH GENERATED FOUR (4) NEGATIVE RESULTS, AND ONE (1) POSITIVE RESULT ON (B)(6) 2024.THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS SORE THROAT AND RUNNY NOSE. ON (B)(6) 2024, THE CUSTOMER WAS PRESCRIBED PAXLOVID BY THEIR HEALTHCARE PROVIDER. THE CONSUMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY. NO ADDITIONAL INFORMATION, INCLUDING DELAY OR IMPACT IN THE PATIENT'S TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT FOR FIVE (5) TESTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FIVE (5). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ONCE MORE ON (B)(6) 2024, TWICE ON (B)(6) 2024, AND TWICE ON (B)(6) 2024 WHICH GENERATED FOUR (4) NEGATIVE RESULTS, AND ONE (1) POSITIVE RESULT ON (B)(6) 2024.THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS SORE THROAT AND RUNNY NOSE. ON (B)(6) 2024, THE CUSTOMER WAS PRESCRIBED PAXLOVID BY THEIR HEALTHCARE PROVIDER. THE CONSUMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY. NO ADDITIONAL INFORMATION, INCLUDING DELAY OR IMPACT IN THE PATIENT'S TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739012 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 220606 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female