BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLISENS® EASYMAG® DISPOSABLE

    MDR report key: 6145757 · Received December 5, 2016

    Report

    Report Number
    3002769706-2016-00481
    Event Type
    Injury
    Date Received
    December 5, 2016
    Report Date
    March 10, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JJH
    PMA / PMN Number
    C1, EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. DURING THE INVESTIGATION, THE ISSUE WAS REPRODUCED WITH SAMPLES BUT WITH A LOWER FREQUENCY. THE ANALYSIS OF DATA PROVIDED BY CUSTOMERS SHOWED THAT THESE ERRORS WERE RANDOMLY DISTRIBUTED WITHIN THE RUN SEQUENCES AND THE SAMPLE POSITIONS. INVESTIGATION WITH THE DISPOSABLE SUPPLIER REVEALED NO ISSUE IN RAW MATERIALS USE. THE ISSUE INVOLVES RISK OF DELAYED RESULTS FOR THE PATIENTS, BUT NOT FALSE RESULTS. AS MENTIONED IN THE EASYMAG USER MANUAL, THE USE OF AN INTERNAL CONTROL IS RECOMMENDED IN ORDER TO DETECT POTENTIAL NUCLEIC ACID EXTRACTION ISSUE. ALL ERRORS THAT OCCUR DURING THE RUNS CAN BE FOUND IN THE RESULTS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A PRODUCT PROBLEM WHEN USING NUCLISENS EASYMAG DISPOSABLE PRODUCT. THE CUSTOMER REPORTED MULTIPLE LLS ISSUES ON THEIR INSTRUMENT, APPROXIMATELY 2-4 TIMES PER USE. THE CUSTOMER INDICATED OCCASIONALLY HAVING DELAYS GREATER THAN 24 HOURS DEPENDING ON THE TIME OF DAY THE LLS ERROR OCCURRED. IN ADDITION, THE CUSTOMER INDICATED HAVING INCIDENCES WHERE THE SAMPLE WAS NSQ FOR REPEAT TESTING THUS REQUIRING RE-COLLECTION FROM THE PATIENT. THE CUSTOMER REPORTED THAT A LARGE MAJORITY OF LLS ERRORS FOR THE PRODUCT LOT ARE OCCURRING IN VESSEL POSITION 7 AND 4, AND RANDOMLY IN OTHER POSITIONS. WHEN THE LLS ERROR OCCURS, RE-EXTRACTION IS REQUIRED EVERY TIME PER CUSTOMER PROCEDURE. THE INSTRUMENT WAS RECENTLY SERVICED AND FOUND TO BE IN GOOD CONDITION. THE DISPOSABLE VESSELS, INSTRUMENT LOG, APPLICATION AND USER LOGS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795547 NUCLISENS® EASYMAG® DISPOSABLE NUCLISENS® EASYMAG® DISPOSABLE JJH BIOMERIEUX SA Z107NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention