BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12100277 · Received July 1, 2021

    Report

    Report Number
    1221359-2021-01859
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    May 12, 2021
    Report Date
    March 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M144031 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 M144031, TEST BASE PART NUMBER 190-430 / LOT M144031. 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 1069485 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    ESTABLISHMENT ADDRESS: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS PERFORMED ON (B)(6) 2021. REPEAT TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS. PCR CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 BEFORE PATIENT WAS ADMITTED TO THE HOSPITAL GENERATED NEGATIVE RESULTS. A SECOND PCR TEST WAS PERFORMED ON (B)(6) 2021 ON A THROAT SWAB SENT TO LAB WAS NOT GOOD. ANOTHER PCR TEST PERFORMED ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THE PATIENT DEVELOPED A FEVER AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995678 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M144031 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other