BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14029976 · Received April 6, 2022

    Report

    Report Number
    1221359-2022-01920
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    January 3, 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: ABBOTT DIAGNOSTICS (B)(4), INC. PERFORMED REVIEW OF MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 195-000 / LOT 133584 AND DEVICE PART NUMBER 195-430H / LOT 131470A. 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 133584 SHOWED THAT THE COMPLAINT RATE IS 0.00034%. 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 FIVE (5) OF ONE HUNDRED THIRTY-THREE (133) AND LOT 1033584 (TOTAL QUANTITY 1). 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. 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
    1912980 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 133584 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female