BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12091933 · Received June 30, 2021

    Report

    Report Number
    1221359-2021-01827
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 11, 2021
    Report Date
    August 16, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1014013 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: 1014013 , TEST BASE PART NUMBER 190-430 / LOT: 1014013 . THE LOT 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 1014013 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. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR. REPORT: 1221359-2021-01880.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH ID NOW COVID-19 ASSAY PERFORMED WITH MULTIPLE PATIENTS ON MULTIPLE DATES. THIS MFR. ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A DIRECT TESTED NASOPHARYNGEAL SWAB WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB WAS PERFORMED WITH PCR AND GENERATED POSITIVE RESULTS. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC. ADDITIONALLY, THERE WAS NO PATIENT HARM DUE TO TEST RESULTS. THERE WAS NO DELAY OR IMPACT OF TREATMENT DUE TO TEST RESULTS. THE PATIENT HAD TO TAKE TWO WEEKS OFF FROM WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992518 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1014013 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization