BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11819496 · Received May 13, 2021

    Report

    Report Number
    1221359-2021-01461
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ABBOTT DIAGNOSTIC SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140860 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: M140860 , TEST BASE PART NUMBER 190-430 / LOT: M140860 . 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 M140860 SHOWED THAT THE COMPLAINT RATE IS 0.03%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 2 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT NASOPHARYNGEAL SWAB. REPEAT TESTING WAS PERFORMED WITH A NEW SAMPLE AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 WITH PCR AND GENERATED NEGATIVE RESULTS. PER THE CUSTOMER THE PATIENTS WERE SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WERE NO PATIENTS HARMED DUE TO TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO IMPACT OR DELAY IN TREATMENT DUE TO TEST RESULTS. PER THE CUSTOMER ADDITIONAL INFORMATION WILL NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715984 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTIC SCARBOROUGH, INC M140860 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1