BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11683041 · Received April 17, 2021

    Report

    Report Number
    1221359-2021-00997
    Event Type
    Injury
    Date Received
    April 17, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 20, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION NARRATIVE (H10). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140860 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 M140860 , TEST BASE PART NUMBER 190-430 / LOT M140860 . 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 M140860 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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE RESULT ON A DIRECT TESTED NASOPHARYNGEAL SWAB WHILE USING THE IDNOW COVID-19 ASSAY ON (B)(6) 2021. REPEAT TESTING ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. PCR CONFIRMATION TESTING ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, THE PATIENT UNDERWENT A DIAGNOSTIC COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2021 TO VERIFY THE POSITIVE RESULT (ID NOW COVID-19 ASSAY) WHICH SHOWED NO FINDINGS OF COVID-19. THE CUSTOMER CONFIRMED THAT NO DEATH OR SERIOUS INJURY OCCURRED AS A RESULT OF THE FALSE POSITIVE. THE CUSTOMER REPORTED THAT TREATMENT WAS NOT IMPACTED BUT WAS DELAYED AS A RESULT OF WAITING FOR THE PCR CONFIRMATION RESULTS AND THE CT SCAN RESULTS. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580362 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140860 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other