BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11616416 · Received April 5, 2021

    Report

    Report Number
    1221359-2021-00876
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 7, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1020714 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT: 1020714, TEST BASE PART NUMBER 190-430/ LOT: 1020714. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS USING 3 DIFFERENT ID NOW COVID-19 ASSAY ON A DIRECT NASAL KITTED SWAB IN VIRAL TRANSPORT MEDIA. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT TULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF 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
    510736 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1020714 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR