BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11346063 · Received February 18, 2021

    Report

    Report Number
    1221359-2021-00521
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL/ INFORMATION INVESTIGATION: THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-000 / LOT 141321 AND DEVICE PART NUMBER 195-430H / LOT 136644A THE LOT MET THE REQUIRED RELEASE SPECIFICATION. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 131848 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 131848 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ASSAY. DATE OF TESTING AND TEST PROCEDURE DETAILS NOT PROVIDED. CONFIRMATORY PCR TESTING PERFORMED TWICE ON UNSPECIFIED DATES (PLATFORM NOT SPECIFIED) GENERATED NEGATIVE RESULTS. REPEAT TESTING ON (B)(6) 2021 WITH THE BINAXNOW COVID-19 AG TEST GENERATED POSITIVE RESULTS. SAMPLE WAS COLLECTED (B)(6) 2021 FOR A THIRD PCR TEST (TEST RESULTS NOT PROVIDED). THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING AND WAS PLACED IN AN ISOLATION ROOM BASED ON THE TEST RESULTS. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. INADEQUATE OR INAPPROPRIATE SAMPLE COLLECTION, STORAGE, AND TRANSPORT MAY YIELD FALSE TEST RESULTS. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238948 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 131848

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR