BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12828485 · Received November 17, 2021

    Report

    Report Number
    1221359-2021-03511
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 18, 2021
    Report Date
    May 2, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION AND CORRECT THE H10 SECTION. PLEASE SEE UPDATES: G3,G4, G6, H2 AND H6. CORRECTION: THE INVESTIGATION CONCLUSION FOR LOT NUMBER M163713 WAS INCORRECTLY REPORTED UNDER 1221359-2021-03509. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M163713 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: M163713,TEST BASE PART NUMBER 190-430 / LOT: M163713 . THE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M163713 SHOWED THAT THE COMPLAINT RATES ARE 0.002% , RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS 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 (3) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021 ON DIRECT TESTED NASAL SWAB SAMPLES AND GENERATED A NEGATIVE RESULTS WITH TWO DIFFERENT LOTS (LOT M164589 AND LOT M163713). THIS MFR. REPORT ADDRESSES PATIENT 3 OF 3. THE CUSTOMER REPORTED (1) ONE FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021 ON A DIRECT TESTED NASAL SWAB. NO REPEAT TESTING WAS PERFORMED. INCYTE RT-PCR CONFIRMATION TESTING ON (B)(6) 2021 WITH A NASAL SWABS GENERATED POSITIVE RESULTS. (CT VALUES NOT PROVIDED). THE PATIENT'S SAMPLE HAD BEEN STORED WELL WITH IN A 24-HOUR TIME FRAME FROM CLINIC TO LAB. PATIENT WAS SYMPTOMATIC 4 DAYS PRIOR TO TESTING. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THE PATIENT WAS NOT TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731346 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M163713

    Patients

    Seq Age Sex Outcome Treatment
    1 Female