BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11220048 · Received January 23, 2021

    Report

    Report Number
    1221359-2021-00028
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    October 26, 2020
    Report Date
    January 22, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 128770 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 KIT PART NUMBER 195-000 / LOT 128770 AND DEVICE PART NUMBER 195-430H / LOT 127588A. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE. BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN THE PACKAGE INSERT IN THE PERFORMANCE CHARACTERISTICS AND CLINICAL PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SUSPECTED 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 CUSTOMER ASKED WHETHER BLOOD ON A SAMPLE COULD GIVE FALSE RESULTS AS PATIENT HAD A BLOODY NOSE AND TESTED POSITIVE. THE SAMPLE COLLECTED WAS REPORTED TO HAVE BLOOD ON. THE NASAL SWAB WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. 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. 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
    116252 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 128770 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR