BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14026786 · Received April 6, 2022

    Report

    Report Number
    1221359-2022-01603
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QKP
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1062351 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 190-000 / LOT 1062351, TEST BASE PART NUMBER 190-430 / LOT 1062351. 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 1062351 SHOWED THAT THE COMPLAINT RATE IS X0.008% (4/53328). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. REFERENCE MFR. REPORTS: 1221359-2022-01601 THROUGH 1221359-2022-01604.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS NOT PERFORMED. (B)(4) INSTRUMENT USED FOR CONFIRMATION TESTING WAS PERFORMED THE SAME DAY WITH A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS A DELAY IN PATIENT'S TREATMENT WITH SURGERY CANCELLED. ADDITIONALLY, THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AND CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4) TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401981 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1062351 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male