BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19

    MDR report key: 11659102 · Received April 13, 2021

    Report

    Report Number
    1221359-2021-00371
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    October 5, 2020
    Report Date
    November 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH,INC.
    Product Code
    QKP
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 125425 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: 125425, TEST BASE PART NUMBER 195-430H / LOT: 125425. 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 125425 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE FOR THESE SPECIFIC TESTS; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE TEST RESULT WITH DIRECT NASAL TESTING OF BINAXNOW COVID-19 AG CARD TEST ASSAY PERFORMED ON (B)(6) 2020. CONFIRMATORY TESTING WAS PERFORMED WITH PCR WHICH GENERATED A NEGATIVE RESULT (CT RESULTS NOT PROVIDED). THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. THE CUSTOMER DOES NOT REPORT WHETHER THE PATIENT WAS SYMPTOMATIC OR NOT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT INTENDED USE: POSITIVE RESULTS INDICATE THE PRESENCE OF VIRAL ANTIGENS, BUT CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF DISEASE. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT INTENDED USE (LIMITATIONS): FALSE RESULTS MAY OCCUR IF SPECIMENS ARE TESTED PAST 1 HOUR OF COLLECTION. SPECIMENS SHOULD BE TESTED AS QUICKLY AS POSSIBLE AFTER SPECIMEN COLLECTION. PER CODE (B)(4) SCR REVE.0 POINT 1, 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
    555973 BINAXNOW COVID-19 LATERAL FLOW IMMUNOASSAYIVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH,INC. 125425 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown