BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12099717 · Received July 1, 2021

    Report

    Report Number
    1221359-2021-01882
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: M149324 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: M149324 , TEST BASE PART NUMBER: 190-430 / LOT: M149324 . 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: M149324 SHOWED THAT THE COMPLAINT (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SAMPLE USING A HEIWA MEDIC CO., LTD. FLOCKED COTTON SWAB FOR THE NASAL CAVITY. THE CUSTOMER REPORTED THAT THE ID NOW COVID-19 ASSAY APPEARED POSITIVE 5 TO 6 MINUTES AFTER THE START OF MEASUREMENT. A BECKMAN COULTER GENE EXPERT CONFIRMATION TEST WAS PERFORMED AND GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT AFTER ABOUT TWO (2) HOURS THE EXTRACT CONTAINING THE SAMPLE WAS RE-EXAMINED AND DISPLAYED A NEGATIVE RESULT. ON (B)(6) 2021, REPEAT TESTING WAS PERFORMED WITH A NEW SAMPLE USING THE ID NOW COVID-19 ASSAY AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC AND STARTED TO GENERATE HEAT (37.4 ). THE PATIENT WAS ISOLATED FOR PRE-HOSPITAL EXAMINATION. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000157 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M149324 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female