BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11919574 · Received June 2, 2021

    Report

    Report Number
    1221359-2021-01589
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    August 30, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025358 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: 1025358 , TEST BASE PART NUMBER 190-430 / LOT: 1025358 . 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 1025358 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED, HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE (UNKNOWN QUANTITY) FALSE POSITIVE RESULTS ON NASAL KITTED SWABS WHILE USING THE ID NOW COVID-19 ASSAY ON (B)(6) 2021 AND THROUGHOUT THE WEEKEND OF (B)(6) 2021. PCR CONFIRMATION TESTING (LABCORE, BIOREFERENCE) WAS PERFORMED AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THAT THE PATIENTS WERE NOT SYMPTOMATIC AND THE TESTS WERE PERFORMED PRE-OPERATION. PER THE CUSTOMER, EACH OF THE PATIENTS' SURGERIES WERE DELAYED DUE TO THE FALSE POSITIVE RESULTS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815815 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1025358 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S