BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17030277 · Received May 31, 2023

    Report

    Report Number
    1221359-2023-01162
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 29, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 207015 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 207015, TEST BASE PART NUMBER 195-430WL/ LOT 203834. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 207015 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    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 TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. ADDITIONAL TESTING WAS PERFORMED (AT A FACILITY) ON (B)(6) 2023 WITH A NON-ABBOTT TEST (PLATFORM - UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (SNEEZING AND RUNNY NOSE) AND HAD EXPOSURE TO COVID-19. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. ADDITIONAL TESTING WAS PERFORMED (AT A FACILITY) ON (B)(6) 2023 WITH A NON-ABBOTT TEST (PLATFORM - UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (SNEEZING AND RUNNY NOSE) AND HAD EXPOSURE TO COVID-19. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296673 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 207015 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female