BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13057813 · Received December 21, 2021

    Report

    Report Number
    1221359-2021-03758
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 22, 2021
    Report Date
    January 21, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M163831 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 M163831 AND TEST BASE PART NUMBER 190-430 / LOT M163831.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 M163831 SHOWED THAT THE COMPLAINT RATE IS 0.004%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID_19 ASSAY PERFORMED (B)(6) 2021 WITH A NASAL SAMPLE ON THE NIPRO SPONGE SWAB AND GENERATED A POSITIVE RESULT. THE CUSTOMER REPORTED THAT REPEAT TESTING WAS PERFORMED WITH THE AND THE SAME CARTRIDGE AND NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER REPORTED A NEW SAMPLE WAS TESTED WITH THE DEVICE AND WAS NEGATIVE AND THE PCR TEST WITH SMART GENE WAS NEGATIVE. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT SYMPTOMATIC. THE CUSTOMER REPORTED THAT THE PATIENT'S EMERGENCY OPERATION WAS DELAYED UNTIL THE OTHER TEST METHOD WAS PERFORMED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951397 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M163831 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other