BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11276137 · Received February 3, 2021

    Report

    Report Number
    1221359-2021-00222
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 3, 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
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE INVESTIGATION IS STILL IN PROGRESS, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000/ LOT 1014216 AND TEST BASE PART NUMBER 190-430/ LOT 1014216 WERE REVIEWED. THIS 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 1014216 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A DIRECT KITTED NASEL SWAB OF BOTH NOSTRILS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 AT 9:00AM. PCR CONFIRMATION TESTING WITH A NASAL SWAB AFTER BEING ADMITTED TO THE HOSPITAL GENERATED A POSITIVE RESULT (DATE OF TEST, PLATFORM AND CT VALUES WERE NOT SPECIFIED). THE PATIENT WAS REPORTED AS SYMPTOMATIC. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN RECEIVING TREATMENT AS A RESULT OF THE ID NOW COVID-19 RESULT. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND TESTED WITH AN ALTERNATIVE FDA AUTHORIZED MOLECULAR ASSAY, IF NECESSARY FOR CLINICAL MANAGEMENT, INCLUDING INFECTION CONTROL. THE PI STATES NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. 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
    168157 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. 1014216 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1