BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD HOME TEST

    MDR report key: 14846681 · Received June 28, 2022

    Report

    Report Number
    1221359-2022-03238
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 7, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA203107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE RELATED MFR. REPORT NUMBERS 1221359-03235 THROUGH 1221359-2022-03241.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 190311 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 KIT PART NUMBER 195-000/ LOT 190311 AND DEVICE PART NUMBER 195-430H/ LOT 176911. 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 190311 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 THE SPECIFIC PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON NASAL SWAB SAMPLES FROM SEVEN PATIENTS ON (B)(6) 2022. THIS REPORT IS FOR PATIENT FOUR (4) OF SEVEN (7). THE PATIENT HAD CONFIRMATORY PCR TESTING PERFORMED WHICH GENERATED A NEGATIVE RESULT (PLATFORM AND SAMPLE TYPE UNKNOWN). THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909297 BINAXNOW COVID-19 AG CARD HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 190311 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female