BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12103043 · Received July 1, 2021

    Report

    Report Number
    1221359-2021-01874
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 21, 2021
    Report Date
    September 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D3, D4 (UDI, EXPIRATION DATE), G1, H2, H6. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140852 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: M140852, TEST BASE PART NUMBER 190-430 / LOT: M140852. 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 M140852 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

    ESTABLISHMENT/REPORTER ADDRESS: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON A DIRECT TESTED NASOPHARYNGEAL SWABS PERFORMED ON (B)(6) 2021. REPEATING TESTING WAS NOT PERFORMED. RT-PCR CONFIRMATION TESTING ( LABORATORY DEVELOPED REAL-TIME PCR TEST THAT DETECTS COVID-19 E AND UTR GENES) ON A NASOPHARYNGEAL GENERATED NEGATIVE RESULT (CT VALUE : RNASE P IS <35.99). THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. 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
    998861 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140852

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO