BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11903130 · Received May 28, 2021

    Report

    Report Number
    1221359-2021-01591
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 16, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025593 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 191-000 / LOT: 1025593, TEST BASE PART NUMBER 190-430 / LOT: 1025593. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (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.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT : 1221359-2021-01590, 1221359-2021-01618 , 1221359-2021-01619. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PER THE CUSTOMER, NO PATIENT HARM OCCURRED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS ON (B)(6) 2021 AND (B)(6) 2021 FOR TWO PATIENTS USING TWO DIFFERENT LOTS. THIS MFR. REPORT ADDRESSES PATIENT TWO AND IS TWO OF FOUR . THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS ON DIRECT TESTED NASOPHARYNGEAL SWABS (FLOQSWABS COPAN) WHILE USING THE IDNOW COVID-19 ASSAY ON (B)(6) 2021. REPEAT TESTING WAS NOT PERFORMED. RT PCR CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIUM ON (B)(6) 2021 GENERATED POSITIVE RESULTS (CT VALUES= FAM 28.14, E ROX 27,51). THE CUSTOMER NOTED THE SAMPLE USED FOR CONFIRMATION TESTING WAS COLLECTED (B)(6)2021. PER THE CUSTOMER, THE PATIENT WAS NOT SYMPTOMATIC AND WAS NOT KNOWN TO BE POSITIVE FOR COVID-19. ALTHOUGH THE CUSTOMER WAS ABLE TO PROVIDE THE FALSE RESULT LEAD TO PERFORMANCE OF AN INCORRECT MEDICAL TREATMENT OR PROCEDURE, PATIENT HARM, TYPE OF TREATMENT AND IMPACT/DELAY WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797705 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025593 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other