BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11720766 · Received April 23, 2021

    Report

    Report Number
    1221359-2021-01199
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 21, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBORUGH, INC
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FROM THE CUSTOMER CLARIFIED THAT THERE WERE ONLY SIX (6) PATIENTS RELATED TO THESE EVENTS AND NOT EIGHT (8) AS PREVIOUSLY REPORTED. THEREFORE, THIS MFR. REPORT IS FIVE (5) OF SIX (6). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013885 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: 1013885 , TEST BASE PART NUMBER 190-430 / LOT: 1013885 . 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 1013885 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORTS: 1221359-2021-01193, 1221359-2021-01195, 1221359-2021-01196, 1221359-2021-01197, 1221359-2021-01198, 1221359-2021-01194, 1221359-2021-01200.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ASSAY WITH MULTIPLE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. ADDRESSES PATIENT 7 OF 8. THE CUSTOMER PROVIDED EIGHT (8) LOT NUMBERS (SOMETIMES REPEATING). HOWEVER, NO INFORMATION RELATING THE LOT NUMBERS TO PATIENTS WAS PROVIDED. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASALPHARYNGEAL KITTED SWAB. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY WITH HOLOGIC AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THE PATIENT WAS A VACCINATED PATIENT WITH NONSPECIFIC SYMPTOMS. ADDITIONALLY, NO OTHER PATIENT INFORMATION WAS PROVIDED. THE CUSTOMER STATED THAT BECAUSE OF FALSE POSITIVE RESULTS THE PATIENT WAS ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616454 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBORUGH, INC 1013885

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR