BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14116645 · Received April 14, 2022

    Report

    Report Number
    1221359-2022-01465
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 9, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR PRODUCT TO (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M178905 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 KIT PART NUMBER 191-000 / LOT M178905 AND TEST BASE PART NUMBER 190-430 / LOT M178905. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M178905 SHOWED THAT THE COMPLAINT RATE IS 0.013%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A DIRECT TESTED KITTED NASAL SWAB THROAT SAMPLE ON (B)(6) 2022. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2022 WITH PROGRESSIVE DYSPNEA AND KNOWN COPD. CONFIRMATION PCR TESTING WAS PERFORMED TWICE ON (B)(6) 2022 WHICH GENERATED A NEGATIVE RESULT (PLATFORM AND SAMPLE TYPE UNKNOWN). THE CUSTOMER INDICATED THAT THE PATIENT'S CT EQUALED 33 PER THE PCR RESULTS. REPEAT PCR TESTING WAS PERFORMED (B)(6) 2022 WHICH GENERATED A POSITIVE RESULT. AS A RESULT, PATIENT WAS ADMITTED TO ICU AND TRANSFERRED TO COVID WARD ON (B)(6) 2022 FOR PLANNED ANTIBODY THERAPY FOR SYMPTOMATIC SARS-COV-2 INFECTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2022. THE CUSTOMER REPORTED THAT "PATIENT STATUS WORSENED ON WEEKEND BEFORE ADMITTANCE, PAIN IN LEFT THORAX, COUGHING WITH FOAMING WHITE SPUTUM" AND THAT THE PATIENT HAD BEEN VACCINATED TWICE AGAINST COVID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139284 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female