BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12982092 · Received December 13, 2021

    Report

    Report Number
    1221359-2021-03725
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 13, 2021
    Report Date
    January 11, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE SEE MFR. REPORT: 1221359-2021-03724 AND 1221359-2021-03726. ALL REPORTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT 190-000J/ LOT M163859 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 M163859. TEST BASE PART NUMBER 191-000/ LOT M163859. 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 M163859 SHOWED THAT THE COMPLAINT RATE IS 0.007% . IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. ABBOTT DIAGNOSTICS (B)(4) 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.

    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 WITH TWO LOT NUMBERS (LOT. M163874 AND LOT M163859) . THIS MFR. REPORT ADDRESSES RESULTS 2 OF 3 USING LOT M163859 . THE CUSTOMER REPORTED (1) ONE FALSE POSITVE ON (B)(6) 2021 (18:12) WITH THE ID NOW COVID-19 ASSAY PERFORMED ON DIRECT TESTED NASOPHARYNGEAL SAMPLES COLLECTED USING COPAN FLOQ SWABS. CONFIRMATION TESTING WAS PERFORMED USING PCR (GENEXPERT LIAT) AND NEGATIVE RESULT WERE OBTAINED THE CUSTOMER REPORTED THAT THE PATIENT WAS SYMPTOMATIC WITH FEVER. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. IN ADDITION, AT THIS FACILITY, TWO ID NOW INSTRUMENTS WERE INSTALLED SIDE BY SIDE IN THE SAFETY CABINET IN THE INSPECTION ROOM. SINCE THERE WAS AN ISSUE NOOTED WITH THE MACHINE THE CUSTOMER STOPPED USING THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886917 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M163859 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown