BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVI® ISOLA

    MDR report key: 5679904 · Received May 25, 2016

    Report

    Report Number
    1950204-2016-00057
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Report Date
    May 19, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED MULTIPLE PATIENT SPECIMENS BEING INOCULATED ONTO THE SAME MEDIA PLATE IN ASSOCIATION WITH THE PREVI® ISOLA SYSTEM. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. INSTRUMENT LOG FILES WERE EVALUATED FOR ENTRIES OR FAILURES THAT WOULD INDICATE A MALFUNCTION CORRESPONDING TO MULTIPLE SAMPLE INOCULATIONS OF DIFFERENT PATIENT SAMPLES ONTO A SINGLE PLATE. LOG FILES WERE ALSO ANALYZED FOR THE PROPER SETTINGS FOR ROTATION ANGLE, SET DOWN ANGLE AND DIRECTION. THESE SETTINGS WERE FOUND TO BE CORRECT. PHOTOS OF THE INOCULATED PLATES WERE ANALYZED. THE PHOTOGRAPHS OF THE PLATES SHOWED: · IMPRINT OF THE APPLICATOR AROUND THE ENTIRE CIRCUMFERENCE OF THE PLATE · TOO MANY INOCULATION LINES · ORGANISM GROWTH AND STREAK PATTERN NOT CONDUCIVE TO A SINGLE INOCULATION THIS DETAIL SUGGESTS THE PLATES HAD ALREADY BEEN INOCULATED, AND THEN RE-INOCULATED. AFTER REVIEWING THE PHOTOS WITH SUBJECT MATTER EXPERTS, A LIKELY USE SCENARIO WAS SUGGESTED: THE PREVI® ISOLA ENCOUNTERS AN ERROR AFTER DISPENSING, AND INSTRUCTS THE USER TO REMOVE THE PLATE FROM PROCESS STATION. THE USER COMPLIES, REMOVES A PROCESSED PLATE WITHOUT A LABEL, AND RETURNS IT TO THE INPUT CASSETTE (HUMAN ERROR), WHERE IT IS RE-PROCESSED SOME TIME LATER. INFORMATION PROVIDED BY THE CUSTOMER ON 10JUN2016 INDICATED THAT THE CUSTOMER MAY HAVE RETURNED PLATES TO THE INPUT CASSETTE FOLLOWING AN ERROR RECOVERY (THERE WAS AN ERROR DOCUMENTED IN THE PREVI® ISOLA LOGS WITH TWO RESPIRATORY SPECIMENS PRIOR TO WHEN THE PLATES IN QUESTION WERE INOCULATED). THE INVESTIGATION CONCLUDED THAT BASED ON THE POSITION AND CLUSTERING OF SOME COLONIES SHOWN IN THE PHOTOGRAPHS, WELL OUTSIDE OF THE STREAKING PATTERN, IT APPEARS VERY LIKELY THAT THE PLATES WERE CONTAMINATED DURING THE ERROR CORRECTION WORKFLOW, AND SHOULD HAVE BEEN DISCARDED. ALSO, THE APPEARANCE OF THE APPLICATOR STREAKING PATTERN SUGGESTS THE PLATES WERE PREVIOUSLY PROCESSED ON A PREVI® ISOLA, I.E. THEY WERE LIKELY INVOLVED IN AN ERROR CONDITION DURING INOCULATION AND WERE RETURNED TO THE INPUT CASSETTE BY THE USER INSTEAD OF BEING DISCARDED. THE PREVI® ISOLA INSTRUMENT IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS ASSOCIATED WITH PREVI ISOLA (REFERENCE 29500) RELATED TO A PROBLEM SEEDING ON CULTURE MEDIA PLATES. CULTURE MEDIA WAS IDENTIFIED AS PVX ANC AND CAN2. THE CUSTOMER INDICATED DISCREPANT RESULTS WERE NOT COMMUNICATED TO A PHYSICIAN AND THERE WAS NO PATIENT IMPACT OR MISTREATMENT. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335306 PREVI® ISOLA PREVI® ISOLA LXG BIOMERIEUX, INC AS180-00336

    Patients

    Seq Age Sex Outcome Treatment
    1