BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14137899 · Received April 18, 2022

    Report

    Report Number
    1221359-2022-02093
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 18, 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

    INVESTIGATION REPORT: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. PERFORMED REVIEW OF MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 195-000 / LOT 157009R AND DEVICE PART NUMBER 195-430H / LOT 148391R. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. RELATED MFR REPORT NUMBERS: 1221359-2022-02077 THROUGH 1221359-2022-02103.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TWENTY-SEVEN (27) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON MULTIPLE DATES IN FEBURARY ON KITTED NASAL SWABS. THIS REPORT IS FOR PATIENT SEVENTEEN (17) OF TWENTY-SEVEN (27) AND LOT 157009 (TOTAL QUANTITY 3). PATIENT WAS TESTED WITH THE BINAXNOW COVID-19 AG CARD ON 07FEB2022 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 SYMPTOMATIC. 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
    657981 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 157009 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male