BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11364822 · Received February 23, 2021

    Report

    Report Number
    1221359-2021-00543
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 23, 2021
    Report Date
    March 26, 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 · 0

    ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER IT COULD POSSIBLY BE RELATED TO SPECIFIC PATIENT SAMPLE AND THE USE OF VIRAL TRANSPORT MEDIA. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Additional Manufacturer Narrative · 1

    REFER TO MRN: 1221359-2021-00542. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013683 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 191-000 / LOT 1013683 AND TEST BASE PART NUMBER 191-430 / LOT 1013683. THE QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1013683 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. 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 INVOLVING ONE (1) PATIENT WITH THE ID NOW COVID-19 ASSAY. THIS REPORT IS REPORT TWO (2) OF TWO (2), AND REPRESENTS LOT 1013683. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON NASOPHARYNGEAL SWABS IN UNIVERSAL TRANSPORT MEDIA WITH THE ID NOW COVID-19 ASSAY (LOT NUMBER 1013556) PERFORMED (B)(6) 2021 AT 1929. CONFIRMATORY TESTING ON (B)(6) 2021 WITH THERMOFISHER PROVIDED NEGATIVE RESULTS. REPEAT TESTING ON (B)(6) 2021 AT 1130 WITH THE ID NOW COVID-19 ASSAY (LOT NUMBER 1013683) PROVIDED POSITIVE RESULTS. CONFIRMATORY TESTING ON (B)(6) 2021 WITH NOVODIAG PROVIDED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH COVID-19 (DIAGNOSTIC METHODOLOGY NOT PROVIDED) ON (B)(6) 2020. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING ON (B)(6) 2021. AFTER RECEIVING A POSITIVE COVID-19 RESULT ON (B)(6) 2021, THE PATIENT WAS PLACED IN A COVID-ZONE. 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
    262206 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013683 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR