BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11602654 · Received April 1, 2021

    Report

    Report Number
    1221359-2021-00853
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    November 14, 2020
    Report Date
    July 1, 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
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1007882 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 1007882, TEST BASE PART NUMBER 190-430 / LOT 1014260. 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 1007882 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON A DIRECT TESTED NASOPHARYNGEAL (NP) SWAB WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2021. CONFIRMATION TESTING ON A NP SWAB IN (B)(6) PROVIDED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, OR TREATMENT IMPACT/DELAY BASED ON THE ID NOW COVID-19 TEST 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
    500572 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1007882 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR