BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYLA V4 VIRTUAL MACHINE

    MDR report key: 11688742 · Received April 19, 2021

    Report

    Report Number
    9615754-2021-00085
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    OUG
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF AN ISSUE IN WHICH NEGATIVE-TO-DATE (NTD) RESULTS FOR BACT/ALERT® BLOOD CULTURE SAMPLES WERE TRANSFERRED TO THE LIS (LABORATORY INFORMATION SYSTEM) WITH A DELAY >24 HOURS IN ASSOCIATION WITH THEIR MYLA® V4 VIRTUAL MACHINE (REF (B)(4), (B)(6). THE INVESTIGATION IDENTIFIED THAT THE BLOCKING OF NTD MESSAGES COULD OCCUR FROM TWO DIFFERENT SCENARIOS. SCENARIO 1: NTD MESSAGES ARE TRANSMITTED FOLLOWING THE SCHEDULE DEFINED IN THE MYLA SOFTWARE BY THE CUSTOMER. THE SOFTWARE ROUTINE TO ESTABLISH THE SCHEDULE FOR THE BOTTLES IS TRIGGERED EVERY MINUTE. EVERY MINUTE, ANY SET OF NEWLY LOADED BOTTLES IS RETRIEVED FROM THE DATABASE. BEFORE ESTABLISHING THE SCHEDULE FOR THESE BOTTLES, A FILTER IS APPLIED TO REMOVE BOTTLES FOR WHICH ALARMS HAVE NOT BEEN ACKNOWLEDGED. THE FILTERED RESULTS LEFT ZERO (0) BOTTLES FOR THE ROUTINE TO ESTABLISH A SCHEDULE. IF ALARMS HAVE NOT BEEN ACKNOWLEDGED BY THE NEXT TIME THE ROUTINE RUNS, THE SAME SET OF BOTTLES WILL BE RETRIEVED FROM THE DATABASE AND ALL WILL BE FILTERED OUT AGAIN. THE NTD MESSAGES ARE NOT TRANSMITTED TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) BECAUSE NO SCHEDULE HAS BEEN ESTABLISHED FOR EACH BOTTLE. SCENARIO 2: NTD MESSAGES CAN ALSO BE BLOCKED FROM BEING TRANSMITTED TO THE LIS IF THE ALARM ON THE INSTRUMENT IS RECEIVED WITH THE SAME TIMESTAMP AS THE ALARM ACKNOWLEDGEMENT. WHEN THE ALARM AND ACKNOWLEDGEMENT ARE RECEIVED WITH THE SAME TIMESTAMP, THE INSTRUMENT WILL STILL SHOW AS BEING IN AN ALARM STATUS INSTEAD OF SHOWING THAT THE ALARM HAS BEEN CLEARED. IN THIS SCENARIO, EVEN IF THE ALARMS WERE ACKNOWLEDGED ON THE INSTRUMENT, THE NTD MESSAGES WERE NOT TRANSMITTED TO THE LIS BECAUSE THE INSTRUMENT WAS STILL CONSIDERED TO BE IN AN ERROR STATE, AND THIS WOULD ALSO LEAD TO THE ISSUES EXPERIENCED IN SCENARIO 1. IN EITHER SCENARIO, THE FINAL POSITIVE OR NEGATIVE RESULTS ASSOCIATED WITH EACH BOTTLE ARE NOT IMPACTED, AND THESE FINAL RESULTS ARE TRANSMITTED AS INTENDED. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE FOR THE ANOMALIES THAT ALLOW SCENARIO 1 AND SCENARIO 2 WAS RELATED TO THE DESIGN OF THE MYLA SOFTWARE. THESE ANOMALIES WILL BE CORRECTED IN THE NEXT MYLA VERSION (MYLA V4.9).

    Description of Event or Problem · 1

    A CUSTOMER FROM FINLAND NOTIFIED BIOMÉRIEUX THAT THEY EXPERIENCED AN ISSUE IN WHICH NEGATIVE-TO-DATE (NTD) RESULTS FOR BLOOD CULTURE SAMPLES WERE TRANSFERRED TO LIS (LABORATORY INFORMATION SYSTEM) WITH A DELAY >24 HOURS IN ASSOCIATION WITH THEIR MYLA® V4 VIRTUAL MACHINE (REF 421993, SERIAL (B)(4)). A TOTAL OF FIFTEEN (15) SAMPLES WERE REPORTED TO HAVE ENCOUNTERED A DELAY IN SENDING NTD FROM THE CUSTOMER'S BACT/ALERT® INSTRUMENT TO THE CUSTOMER'S LIS. ON (B)(6) 2021, IT WAS CONFIRMED THAT THE 15 SAMPLES BELONGED TO 15 DIFFERENT PATIENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 14. REPORT 9615754-2021-00045 WILL BE USED FOR REPORTING RELATED TO PATIENT 1. GLOBAL CUSTOMER SERVICE (GCS) REQUESTED ASSISTANCE FROM RESEARCH & DEVELOPMENT (R&D) AND CONFIRMED THAT SOME PREVIOUS ALARMS, THAT THE CUSTOMER HAD NOT CLEARED, WERE HOLDING UP THE TRANSFER OF THE NTD RESULTS. THE ALARMS WERE CLEARED AND IT WAS CONFIRMED THAT THE NTD RESULTS WERE SUCCESSFULLY SENT, AND ARE NO LONGER BEING BLOCKED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585609 MYLA V4 VIRTUAL MACHINE MYLA® V4 VIRTUAL MACHINE OUG BIOMERIEUX, SA 421993

    Patients

    Seq Age Sex Outcome Treatment
    1