BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18050163 · Received November 1, 2023

    Report

    Report Number
    1221359-2023-01604
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 6, 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

    (B)(4) THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    FDA UDI (B)(4) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213213 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 213213 AND TEST DEVICE 195-430H / LOT 207452. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213213 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, AS WELL AS CUSTOMER MISUSE, DUE TO THE CUSTOMER ADDING THE REAGENT DROPS TO THE TEST CARD AFTER THE SAMPLE WAS COLLECTED AND SWAB WAS INSERTED INTO THE CARD FOR THE TESTS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023. H3 OTHER TEXT : SINGLE-USE: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE POSITIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. THIS MANUFACTURER'S REPORT ADDRESSES TEST TWO (2) OF THREE (3). ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS WERE PERFORMED ON (B)(6) 2023 AND GENERATED POSITIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED 2 CELLTROIN DIATRUST COVID-19 AG RAPID TESTS ON (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. THE CONSUMER WAS ASYMPTOMATIC. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE POSITIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. THIS MANUFACTURER'S REPORT ADDRESSES TEST TWO (2) OF THREE (3). ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS WERE PERFORMED ON (B)(6)2023 AND (B)(6) 2023 AND GENERATED POSITIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED 2 CELLTROIN DIATRUST COVID-19 AG RAPID TESTS ON (B)(6) 2023 AND (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. THE CONSUMER WAS ASYMPTOMATIC. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043636 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 213213 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male