BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12487750 · Received September 17, 2021

    Report

    Report Number
    1221359-2021-02653
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 23, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162751 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: M162751 , TEST BASE PART NUMBER 190-430 / LOT: M162751 . 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 M162751 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORT: 1221359-2021-02651, 1221359-2021-02652, 1221359-2021-02654.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (4) FOUR UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH MULTIPLE PATIENTS. THIS MFR REPORT ADDRESSES PATIENT THREE (3) OF FOUR (4). THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT ON A NASAL SWAB WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED WITH A NEW SAMPLE. PER THE CUSTOMER, THERE WAS NO PATIENT HARM DUE TO THE RESULTS. ADDITIONALLY, THERE WAS NO IMPACT OR DELAY IN TREATMENT DUE TO TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387447 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162751 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male