BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12047051 · Received June 22, 2021

    Report

    Report Number
    1221359-2021-01759
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. MFR.REFERENCE: 1221359-2021-01758.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 FOR TWO (2) PATIENTS PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING (PLATFORM: DIAGENODE) GENERATED NEGATIVE. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC AND PATIENT WAS TESTED POSITIVE FOR COVID IN (B)(6) 2021. IT WAS NOTED,THAT PATIENT HAS BEEN ADMITTED IN COVID AREA WITH HIGH RISK OF CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942489 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025597 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR