BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14083865 · Received April 12, 2022

    Report

    Report Number
    1221359-2022-01916
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    January 3, 2022
    Report Date
    April 12, 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

    (B)(4). INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS (B)(4). ON RETAINED KIT LOT 153683 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 195-000 / LOT 153683, CARD DEVICE PART NUMBER 195-430H / LOT 147123A. 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 153683 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4). WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE HUNDRED THIRTY-SEVEN (137) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON MULTIPLE DATES IN JANUARY ON KITTED NASAL SWABS. THIS REPORT IS FOR PATIENT ONE (1) OF ONE HUNDRED THIRTY-THREE (133) AND LOT 153683 (TOTAL QUANTITY 10). 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: PERKINELMER) 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
    1278470 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153683 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male