BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18510626 · Received January 15, 2024

    Report

    Report Number
    1221359-2024-00059
    Event Type
    Malfunction
    Date Received
    January 15, 2024
    Date of Event
    December 30, 2023
    Report Date
    February 12, 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

    D4: UDI (B)(4) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 226491 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 226491 AND DEVICE PART NUMBER 195-430H/ LOT 223470. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 226491 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 POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.A1 H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT USING BINAXNOW COVID-19 AG SELF TEST ON (B)(6)2023 WITH AN UNKNOWN SAMPLE TYPE. PCR TESTING WAS PERFORMED TWO DAYS PRIOR (B)(6)2023 GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT USING BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2023 WITH AN UNKNOWN SAMPLE TYPE. PCR TESTING WAS PERFORMED TWO DAYS PRIOR (B)(6) 2023 GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT USING BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2023 WITH AN UNKNOWN SAMPLE TYPE. PCR TESTING WAS PERFORMED TWO DAYS PRIOR (B)(6) 2023 GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730354 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 226491 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male