BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 AG CARD

    MDR report key: 13161688 · Received January 4, 2022

    Report

    Report Number
    1221359-2022-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 8, 2021
    Report Date
    April 7, 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

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR REPORTS: 1221359-2022-00005, 1221359-2022-00007.

    Additional Manufacturer Narrative · 0

    THE REQUIRED INTAKE 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, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. 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. REFERENCE MFR NUMBERS : 1221359-2-22-00005, 1221359-2-22-00007.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE BINAXNOW¿ COVID-19 AG CARD TEST FOR THREE (3) PATIENTS PERFORMED IN DECEMBER. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF THREE (3). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 AG CARD TEST. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270764 BINAXNOW¿ COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown