BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17221823 · Received June 28, 2023

    Report

    Report Number
    1221359-2023-01249
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 18, 2023
    Report Date
    July 18, 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 192376 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 192376 AND DEVICE PART NUMBER 195-430H / LOT 187910. 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 192376 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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 : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. PER THE CONSUMER, THEY RECEIVED A POSITIVE RESULT ON (B)(6) 2023, AND A NEGATIVE RESULT ON (B)(6) 2023 ON BINAXNOW COVID-19 AG SELF-TEST. THE CONSUMER PERFORMED A RAPID ANTIGEN TEST BRAND (UNKNOWN) ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. THE CONSUMER WAS SYMPTOMATIC A FEW DAYS BEFORE TESTING. ADDITIONALLY, THE CONSUMER SATED THAT THEY ARE FEELING FINE. A CONFIRMATORY TEST WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6)2023. PER THE CONSUMER, THEY RECEIVED A POSITIVE RESULT ON (B)(6)2023, AND A NEGATIVE RESULT ON (B)(6)2023 ON BINAXNOW COVID-19 AG SELF-TEST. THE CONSUMER PERFORMED A RAPID ANTIGEN TEST BRAND (UNKNOWN) ON (B)(6)2023 AND GENERATED A NEGATIVE RESULT. THE CONSUMER WAS SYMPTOMATIC A FEW DAYS BEFORE TESTING. ADDITIONALLY, THE CONSUMER SATED THAT THEY ARE FEELING FINE. A CONFIRMATORY TEST WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308507 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192376 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown