MAUDE Adverse Event Report: BIOMERIEUX, SA SYS-MYLA; SYS-MYLA®

Catalog Number 4700384

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of an instance where an email was not sent to notify the customer of a positive bottle in association with the customer's virtuo® (vrtb-00311), myla®, and lis.The customer stated that a positive bottle was flagged by the virtuo® on (b)(6) 2020 at 10:41 pm and was not unloaded by the system until the next day at 09:07 am.The customer also stated that myla® failed to send an alert email for the positive bottle when the bottle was initially detected as positive.The customer is a blood bank customer and currently uses the email notifications for positive bottles to ensure that they can stop the corresponding blood batch from being delivered to patients.Global customer service (gcs) review of the customer's "out.Log" file confirmed that no email was sent to correspond with the positive bottle result detected on (b)(6) 2020 at 10:41 pm.However, further review by gcs identified that the virtuo® sent the positive result to myla® and then myla® sent the positive result to the customer's lis.There was no delay of the result being reported from the virtuo® to the customer's lis.The customer confirmed that this event did not lead to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.The customer is performing manual instrument checks while this issue is being investigated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in australia regarding an instance where an email was not sent to notify the customer of a positive bottle in association with the customer's virtuo® (vrtb-00311), myla®, and lis.The investigation included a review of the customers ¿out log¿ files performed on the server through vilink®.The log files showed a positive bottle was detected on (b)(6) 2020 at midnight, but no e-mail alert was sent, although the alert server configuration feature was set to ¿on¿.No error logs were found.A root cause has not been clearly identified.A possible cause is the customer¿s non-validated third party software (security scan) interfering with myla® software/services; however, biomerieux was not able to confirm it.Biomerieux informed the customer that the e-mail channel is not secured and robust enough to base a workflow on it and/or to trigger an on-call team intervention.Only the myla® gui and the lis communication are features dedicated for result rendering.

• Brand Name: SYS-MYLA
• Type of Device: SYS-MYLA®
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10203152
• MDR Text Key: 222188272
• Report Number: 9615754-2020-00108
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 03573026369774
• UDI-Public: 03573026369774
• Combination Product (y/n): N
• PMA/PMN Number: C 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4700384
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1