BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11318649 · Received February 11, 2021

    Report

    Report Number
    1221359-2021-00245
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    February 11, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER AND LOGFILES, WAS NOT PROVIDED TO ABBOTT DIAGNOSTICS SCARBOROUGH, INC. THEREFORE, A ROOT CAUSE INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A REVIEW OF COMPLAINTS' TREND REVEAL THAT ALL OF THE BINAXNOW COVID-19 AG CARD LOTS WITHIN EXPIRY ARE PERFORMING ACCORDING TO LABEL CLAIMS. IN CONCLUSION, THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. PLEASE SEE RELATED MFR REPORT #S:1221359-2021-00300.

    Description of Event or Problem · 1

    IN RESPONSE TO THE EVENT REPORTED UNDER MFR. REPORT 1221359-2021-00230, THE CUSTOMER REPORTED DISCREPANT RESULTS WITH THE BINAXNOW COVID-19 AG CARD. THE CUSTOMER REPORTED FOR MOST OF THE STATE TESTS, THE ANTIGEN WILL PICK UP ABOUT 70% OF THOSE WHO TEST PCR POSITIVE. FURTHER INVESTIGATION OF THE INFORMATION PROVIDED BY THE CUSTOMER IDENTIFIED FALSE NEGATIVES AND FALSE POSITIVES WITH PCR CONFIRMATION. THIS MFR. REPORT ADDRESSES THE FALSE POSITIVES. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, FURTHER INVESTIGATION IDENTIFIED THE INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS IS (B)(4). ALTHOUGH REQUESTED, ADDITIONAL CLARIFYING INFORMATION HAS NOT BEEN RECEIVED. 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
    215515 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1