BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11980326 · Received June 10, 2021

    Report

    Report Number
    1221359-2021-01739
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Report Date
    December 5, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M142049 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 M142049 AND TEST BASE NUMBER 190-430 / LOT M142049. 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 M142049 SHOWED THAT THE COMPLAINT RATE IS 0.005%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED. A REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. MFR REFERENCE: 1221359-2021-01733.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VARIOUS FALSE POSITIVE RESULTS ACROSS VARIOUS SITES WITH THE ID NOW COVID-19 ASSAY. THIS MFR. REPORT ADDRESSES THE FALSE POSITIVES FOR WHICH THE CUSTOMER WAS NOT ABLE TO PROVIDE THE LOT # FOR AND IS TWO (2) OF TWO (2). THE CUSTOMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED IN VARIOUS LOCATIONS OVER THE PAST SEVERAL MONTHS (CONFIRMED BY FOLLOW-UP NEGATIVE RESULTS,PLATFORM UNKNOWN) NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876455 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown