BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12332025 · Received August 17, 2021

    Report

    Report Number
    1221359-2021-02307
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Report Date
    December 8, 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
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022161 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 191-000 / LOT: 1022161 , TEST BASE PART NUMBER 190-430 / LOT: 1022161 . 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 1022161 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1022161 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED WITH AN ANITGEN TEST AND THAT GENERATED POSITIVE RESULTS. REPEAT TESTING WAS PERFORMED WITH ID NOW COVID-19 ASSAY AND GENERATED POSITIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229605 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022161 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown