BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17146451 · Received June 16, 2023

    Report

    Report Number
    1221359-2023-01213
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 11, 2023
    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 224382 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 KIT PART NUMBER 195-160/ LOT 224382 AND TEST BASE PART NUMBER 195-430H/ LOT 221669. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 224382 SHOWED THAT THE COMPLAINT RATE IS 0.00155% RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. H3 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    B3: 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. H3 : SINGLE-USE: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. PER THE CONSUMER, FIVE (5) TOTAL BINAXNOW ANTIGEN SELF-TESTS WERE TAKEN, HOWEVER, THE DATES AND TIMES OF THE TESTS WERE NOT PROVIDED. ONE (1) TEST GENERATED A NEGATIVE RESULT, WHICH WAS REPORTEDLY THE FIRST TEST CONDUCTED AND THE CONSUMER CONSIDERED THE RESULT AS ACCURATE. NO INFORMATION WAS PROVIDED ON WHY THE CONSUMER CONSIDERED THE NEGATIVE TEST RESULT AS ACCURATE. THE CONSUMER PROCEEDED TO TAKE FOUR (4) MORE TESTS THAT GENERATED POSITIVE RESULTS. IT IS UNCLEAR WHETHER THE TESTS WERE PERFORMED ON THE SAME DAY OR ACROSS SEVERAL DAYS OR WEEKS. NO INFORMATION WAS PROVIDED REGARDING CONFIRMATION TESTING. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. PER THE CONSUMER, FIVE (5) TOTAL BINAXNOW ANTIGEN SELF-TESTS WERE TAKEN, HOWEVER, THE DATES AND TIMES OF THE TESTS WERE NOT PROVIDED. ONE (1) TEST GENERATED A NEGATIVE RESULT, WHICH WAS REPORTEDLY THE FIRST TEST CONDUCTED AND THE CONSUMER CONSIDERED THE RESULT AS ACCURATE. NO INFORMATION WAS PROVIDED ON WHY THE CONSUMER CONSIDERED THE NEGATIVE TEST RESULT AS ACCURATE. THE CONSUMER PROCEEDED TO TAKE FOUR (4) MORE TESTS THAT GENERATED POSITIVE RESULTS. IT IS UNCLEAR WHETHER THE TESTS WERE PERFORMED ON THE SAME DAY OR ACROSS SEVERAL DAYS OR WEEKS. NO INFORMATION WAS PROVIDED REGARDING CONFIRMATION TESTING. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679486 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 224382 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female