BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12701783 · Received October 26, 2021

    Report

    Report Number
    1221359-2021-03311
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 1, 2021
    Report Date
    December 15, 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
    ID
    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 190-000/ LOT M162544 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 190-430 / LOT M162544 . TEST BASE PART NUMBER 190-000 / LOT M162544. 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 M162544 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. 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. 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. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    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 (3) THREE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON OROPHARYNGEAL SAMPLES ON DIRECT TESTED THROAT SWABS AND GENERATED POSITIVE RESULTS. REPEAT TESTING WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON TWO OF POSITIVE PATIENTS USING A NASOPHARYNGEAL SAMPLE AND GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT PCR CONFIRMATION TESTING WAS PERFORMED (B)(6) 2021 ON ALL THREE PATIENTS USING NASOPHARYNGEAL SAMPLES ON THROAT SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE THREE PATIENTS WERE NOT SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599251 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162544 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown