BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12156061 · Received July 13, 2021

    Report

    Report Number
    1221359-2021-01939
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 15, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6 AND H2. THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUIRED INTAKE INFORMATION. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION OR VIGILANCE REPORTING.

    Additional Manufacturer Narrative · 1

    THE ESTABLISHMENT NAME EXCEEDS THE CHARACTER LIMITS OF INITIAL REPORTER: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE MFR. REPORT #S: 1221359-2021-01944.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULT WITH THE BINAX NOW COVID-19 AG CARD USING AN UNSPECIFIED LOT (139666 OR 133584) PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES LOT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAX NOW COVID-19 AG CARD PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL (ANTERIOR NASAL) SWAB. THE CUSTOMER REPORTED THAT ON (B)(6) 2021 THE PATIENT'S FIRST TESTED NEGATIVE WITH THE BINAX NOW COVID-19 AG CARD. REPEAT TESTING WAS PERFORMED WITH THE BINAX NOW COVID-19 AG CARD ON (B)(6) 2021 USING A NEW SAMPLE AND AGAIN THE PATIENT RESULTS WERE NEGATIVE . PCR CONFIRMATION TESTING (TAQPATH ASSAY) WAS PERFORMED (B)(6) 2021 ON A NASAL SWAB AND GENERATED NEGATIVE RESULTS. 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 TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057128 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 139666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown