BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17948930 · Received October 17, 2023

    Report

    Report Number
    1221359-2023-01551
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 24, 2023
    Report Date
    October 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

    FDA UDI ¿ (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225549 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 225549 AND TEST BASE PART NUMBER 195-430H / LOT 222066. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225549 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

    FDA UDI ¿ (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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A DIFFERENT BRAND ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A DIFFERENT BRAND ON (B)(6)2023 AND GENERATED ANOTHER POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC ON (B)(6)2023; HOWEVER, THE SYMPTOMS HAD RESOLVED BY (B)(6)2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A DIFFERENT BRAND ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. CONSUMER PERFORMED AN ANTIGEN SELF-TEST WITH A DIFFERENT BRAND ON (B)(6)2023 AND GENERATED ANOTHER POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC ON (B)(6) 2023; HOWEVER, THE SYMPTOMS HAD RESOLVED BY (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97348 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225549 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female