BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11900114 · Received May 28, 2021

    Report

    Report Number
    1221359-2021-01613
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 25, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORT: 1221359-2021-01549, 1221359-2021-01614, 1221359-2021-01615. (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1017966 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: 1017966, TEST BASE PART NUMBER 190-430 / LOT: 1017966 . 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 1017966 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 4 FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON MULTIPLE DATES WITH MULTIPLE PATIENTS. THIS MFR. ADDRESSES PATIENT 2 OF 4. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON DIRECT TESTED NASOPHARYNGEAL SWABS. CONFIRMATION TESTING WAS PERFORMED ON NASOPHARYNGEAL SWABS IN VIRAL MEDIUM TRANSPORT WITH PCR (CNR AND SEEGENE TECHNIQUES) AND GENERATED NEGATIVE RESULTS. RAPID TEST (NAME NOT PROVIDED) WAS POSITIVE FOR COVID-19 IN THE EMERGENCY DEPARTMENT. THE CUSTOMER STATED THAT THE PATIENT WAS HOSPITALIZED IN PNEUMOLOGY DEPARTMENT FROM (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795674 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1017966 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR