BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11572739 · Received March 25, 2021

    Report

    Report Number
    1221359-2021-00800
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    January 24, 2021
    Report Date
    March 25, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 140496 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: 140496, TEST BASE PART NUMBER 195-430H / LOT 135726. 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 140496 SHOWED THAT THE COMPLAINT RATE (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. DURING INTAKE, IT WAS ADVISED THAT A SAMPLE WAS OBTAINED FROM THE PATIENTS STOMA. PLEASE NOTE, PER THE PACKAGE INSERT THE BINAXNOW COVID-19 AG ASSAY IS INTENDED FOR USE WITH ANTERIOR NASAL (NARES) SWAB SPECIMENS ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAX NOW COVID-19 AG CARD ASSAY PERFORMED ON VARIOUS DATES FOR ONE (1) PATIENT. PATIENT 1 HAD AN OPEN STOMA (LARYNX) ON (B)(6) 2021, PATIENT 1 RECEIVED NEGATIVE BINAXNOW RESULT AS THIS IS THE CONFLICTING RESULT. IT WAS REPORTED THE CUSTOMER REPORTED NEGATIVE RESULTS USING THE BINAX NOW COVID-19 AG CARD ASSAY ON (B)(6) 2021. CONFIRMATION TESTING ON (B)(6) 2021 WITH PCR GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. BINAX NOW COVID-19 AG CARD ASSAY WAS PERFORMED ON (B)(6) 2021 USING A SAMPLE FROM AN OPEN STOMA (LARYNX), WHICH IS CONSIDERED TO BE OFF LABEL USE. THE OPEN STOMA SWAB GENERATED POSITIVE RESULTS FOR BINAX NOW COVID-19 AG ASSAY AND FOR PCR CONFIRMATION TESTING; CT VALUES NOT PROVIDED. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC WITH COUGH AND EXTREME FATIGUE WHICH BEGAN ON (B)(6) 2021. THE CUSTOMER REPORTED THE PATIENT'S HEALTH WAS VERY COMPROMISED. IT WAS REPORTED THE PATIENT LEFT THE FACILITY ON (B)(6) 2021 AND DIED IN HOSPITAL CARE ON (B)(6) 2021. IT WAS REPORTED THE PATIENT'S DEATH WAS NOT CAUSED BY THE CONFLICTING BINAX NOW COVID-19 AG CARD ASSAY RESULTS. THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE FACILITY WITH NEGATIVE BINAX NOW COVID-19 ASSAY RESULTS BUT BECAME SYMPTOMATIC AND CAUSED A SMALL COVID-19 OUTBREAK IN THE FACILITY. 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. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND CONFIRMATION WITH A MOLECULAR ASSAY, IF NECESSARY, FOR PATIENT MANAGEMENT, MAY BE PERFORMED. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR PATIENT MANAGEMENT DECISIONS, INCLUDING INFECTION CONTROL DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465110 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 140496 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other