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

Catalog Number 4700384

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a data integration issue when using the myla® system (ref.4700384, serial (b)(4)) in conjunction with their virtuo® instrument.The customer confirmed the patient bottle incubation time was adjusted from five (5) days to fourteen (14) days at the lis (laboratory information system).However, the impacted bottle was expelled from the virtuo after five (5) days of incubation and showed a result of negative.The customer noticed the bottle should not have been expelled and reloaded it on the virtuo and completed its incubation.There is no indication or report from the laboratory that the premature bottle expulsion led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

Biomérieux conducted an internal investigation in response to a customer complaint of data integration issue when using the myla® system (ref.4700384, serial (b)(6)) in conjunction with their virtuo® instrument.A patient bact/alert® bottle was automatically unloaded from the virtuo® instrument after five (5) days of incubation instead of the set fourteen (14) days.Biomérieux reviewed the customer¿s lis logs.This review found that two (2) messages with the same information were sent at the same time.It was also confirmed the that was not present in the maximum test time (mtt).Biomérieux confirmed if is not present when updating the mtt, the test time will remain five (5) days of incubation.These details on adjusting the mtt are present in the service manual - 161150-1283 - a - en - connectivity bci - myla 4.X ¿ lis.The investigation concluded the instructions in the service manual for adjusting the maximum test time were not followed and that the myla® system is performing as intended.

• 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: 9877612
• MDR Text Key: 224739190
• Report Number: 9615754-2020-00046
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• 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: 07/09/2020

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: 02/18/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1