BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12615479 · Received October 12, 2021

    Report

    Report Number
    1221359-2021-03112
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 22, 2021
    Report Date
    December 10, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162309 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 190-000J / LOT M162309, TEST BASE PART NUMBER 190-430 / LOT M162309. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND/OR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M162309 SHOWED THAT THE COMPLAINT RATE FOR FALSE POSITIVE IS (B)(4) AND FALSE NEGATIVE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A NASOPHARYNGEAL SWAB. REPEAT TESTING WAS PERFORMED. RESULTS ON ID NOW COVID-19 ON (B)(6) 2021 WERE NEGATIVE. RETESTING WAS PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING ON NASOPHARYNGEAL SWAB WITH TRC METHOD GENERATED NEGATIVE RESULT. ANTIGEN TEST GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING ON (B)(6) 2021 ON NASOPHARYNGEAL SWABS WITH TRC METHOD GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). ANTIGEN TEST GENERATED NEGATIVE RESULTS ON (B)(6) 2021. PATIENT HAD A FEVER OF 37.6°C ON (B)(6) 2021, ROSE TO 37.9°C ON (B)(6) 2021, AND WAS TESTED ON (B)(6) 2021 WITH THE ABOVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515045 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162309 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female