BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12280775 · Received August 5, 2021

    Report

    Report Number
    1221359-2021-02191
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    July 8, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H10 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025742 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: 1025742, TEST BASE PART NUMBER 190-430 / LOT:1025742. 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 M149779 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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 NASOPHARYNGEAL SWAB (SEC COPAN). CONFIRMATION TESTING WAS PERFORMED ON INGENIUS INSTRUMENT WITH THE NEW SAMPLE GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC TO COVID-19 AND HAD SYMPTOMS FOR HYPOTENSION MALAISE. CUSTOMER CONFIRMED THAT PATIENT WAS HOSPITALIZED IN COVID ZONE FOR 24 HOURS ON (B)(6) 2021 FOR CONFIRMATION ASSAY RESULT AND RELEASED ON (B)(6) 2021 IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178708 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025742 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Hospitalization