BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11965116 · Received June 9, 2021

    Report

    Report Number
    1221359-2021-01700
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 7, 2021
    Report Date
    November 19, 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
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022797 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: 1022797 , TEST BASE PART NUMBER 190-430 / LOT: 1022797 . 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 1022797 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILE WAS NOT RETURNED FOR INVESTIGATION, HOWEVER DUE TO THE NATURE OF THE COMPLAINT, AMPLICON CONTAMINATION IS SUSPECTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A UNKNOWN SAMPLE. ALTHOUGH REQUESTED NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860369 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022797 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown