BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14030206 · Received April 6, 2022

    Report

    Report Number
    1221359-2022-01993
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    January 12, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT IDENTIFIER: (B)(6). INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 150358 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 150358 AND DEVICE PART NUMBER 195-430H / LOT 146923. 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 150358 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. RELATED MFR REPORT NUMBERS: 1221359-2022-01916 THROUGH 1221359-2022-02048.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE HUNDRED THIRTY-SEVEN (133) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON MULTIPLE DATES IN (B)(6) ON KITTED NASAL SWABS. THIS REPORT IS FOR PATIENT SEVENTY-EIGHT (78) OF ONE HUNDRED THIRTY-THREE (133) AND LOT 150358 (TOTAL QUANTITY 5). PATIENT WAS TESTED WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2022 WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR NASAL SAMPLE WAS COLLECTED THE SAME DAY, PLACED IN VTM, AND TRANSPORTED VIA CURRIER TO A SEPARATE BRANCH LAB FOR TESTING (PLATFORM: (B)(6)) WHICH GENERATED A NEGATIVE RESULT. THE PATIENT WAS ASYMPTOMATIC BUT WAS KNOWN TO BE COVID-19 POSITIVE AT THE TIME OF TESTING. NO SERIOUS INJURY, MEDICAL INTERVENTION OR TREATMENT DECISIONS OCCURRED AS A RESULT. CUSTOMER IS PERFORMING TESTS IN COMMUNITY ORGANIZATIONS (COHORT 1: K-12 SCHOOLS INCLUDING FACULTY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048964 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 150358 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male