BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19

    MDR report key: 11566297 · Received March 24, 2021

    Report

    Report Number
    1221359-2021-00793
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 15, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011321
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION NARRATIVE (H10). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1018106 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 191-000 / LOT 1018106, TEST BASE PART NUMBER 190-430 / LOT 1018106. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1018106 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER IT COULD BE RELATED TO THE SPECIFIC PATIENT SAMPLES OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    REFER TO MRNS: 1221359-2021-00794. THE INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS REPORT ONE (1) OF TWO (2). THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON A DIRECT TESTED NASOPHARYNGEAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021. CONFIRMATION BY THERMOFISHER TAQPATH PCR PERFORMED THAT SAME DAY PROVIDED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE ID NOW COVID-19 ASSAY RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT WAS PLACED IN A DOUBLE ROOM COVID-UNIT OF THE HOSPITAL AFTER THE ID NOW COVID-19 ASSAY RESULTS. THE PATIENT WAS NOT SYMPTOMATIC AT THE TIME OF TESTING. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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 A 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
    459442 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1018201 10811877011321

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization