BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16935099 · Received May 15, 2023

    Report

    Report Number
    1221359-2023-01133
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    May 8, 2023
    Report Date
    June 20, 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 212342 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: 212342, TEST BASE PART NUMBER 195-430WJR / LOT 209880. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 212342 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. 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 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT PERFORMED WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON A NASAL SAMPLE ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED THE SAME DAY FROM A DIFFERENT BRAND (IHEALTH) AND GENERATED NEGATIVE RESULT. THE CONSUMER RETESTED WITH ANOTHER IHEALTH BRAND TEST (DATE UNKNOWN) WHICH GENERATED A POSITIVE RESULT, SO THEY DECIDED TO QUARANTINE FOR 5 DAYS. THE CONSUMER RETESTED (DATE UNKNOWN) WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON A NASAL SAMPLE WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED THE SAME DAY FROM A DIFFERENT BRAND (IHEALTH) AND GENERATED NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351022 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212342 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown