BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11677486 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-00483
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    September 25, 2020
    Report Date
    April 16, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 124410 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: 124410, TEST BASE PART NUMBER 195-430 / LOT: 124410. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 124410 SHOWED THAT THE COMPLAINT RATE IS (B)(4) . ABBOTT DIAGNOSTICS (B)(4), INC. 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 SAMPLES. 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 RESULT WITH THE BINAX NOW COVID-19 AG CARD ASSAY PERFORMED ON (B)(6) 2020 ON A DIRECT TESTED NASAL KITTED SWAB. THE NASAL SWAB WAS USED TO SWAB ONE NOSTRIL PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS PERFORMED, GENERATED A POSITIVE RESULT. A PRIOR PCR TEST WAS PERFORMED ON (B)(6) 2020, GENERATED A NEGATIVE RESULT. ( CT VALUE NOT PROVIDED). THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. 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. "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
    574398 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY QKP ABBOTT DIAGNOSTICS SCARBOROUGH INC. 124410

    Patients

    Seq Age Sex Outcome Treatment
    1