BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11133597 · Received January 7, 2021

    Report

    Report Number
    1221359-2021-00172
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 29, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1012409 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1012409 SHOWED THAT THE COMPLAINT RATE IS (B)(4) ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT 190-000/ LOT 1012409 AND TEST BASE PART NUMBER 190-430/ LOT 1012409. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON DIRECT TESTED NASAL KITTED SWABS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2020. REPEAT TESTING ON A NEW DIRECT TESTED NASAL KITTED SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2020 GENERATED NEGATIVE RESULTS. TWO CONFIRMATION TESTING BY PCR (DATE OF COLLECTION NOT PROVIDED) GENERATED POSITIVE RESULTS (CT VALUE NOT PROVIDED). THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE ID NOW COVID-19 ASSAY RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT WAS IMPACTED BY THE ID NOW COVID-19 ASSAY RESULTS BECAUSE THE TREATMENTS OF STEROIDS AND INHALERS WERE DELAYED. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF TESTING. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND, IF INCONSISTENT WITH CLINICAL SIGNS AND SYMPTOMS OR NECESSARY FOR PATIENT MANAGEMENT, SHOULD BE TESTED WITH DIFFERENT AUTHORIZED OR CLEARED MOLECULAR TESTS. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. ADDITIONALLY, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. DUE TO THE RISK OF A FALSE NEGATIVE RESULT POTENTIALLY LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29030 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012409 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR