BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    MDR report key: 19851421 · Received July 29, 2024

    Report

    Report Number
    1221359-2024-00521
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    PMA / PMN Number
    K221925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGSDATE OF EVENT PROVIDED IN SECTION B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER.THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ABOUT WHICH ASSAY TYPE WAS USED TO PERFORM THE TEST. THIS REPORT IS BEING SUBMITTED OUT OF CAUTION. 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.ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST ASSAY PERFORMED ON AN UNKNOWN DATE. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384435 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown