MAUDE Adverse Event Report: BIOMERIEUX SA MYLA SERVER HP DL 380

Catalog Number 415603

Device Problems Computer Software Problem (1112); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states notified biomerieux of an issue associated with myla.¿the customer reported experiencing a problem with their data not crossing over to their lis system.In addition, the customer indicated they and could not launch myla and received an error message indicating service was temporarily unavailable.Biomerieux initiated troubleshooting, examination of data logs and performed a full system restore, which resolved the problem.However, the customer indicated test results were not available for two (2) days while the myla system was down.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states notified biomérieux of an issue associated with myla® involving data not crossing over to the lis.An internal biomérieux investigation was performed.Biomérieux restored the system to a working state and with customer's agreement, took the full system backup (fsb) from13oct2016 for investigation purpose.Investigation of the fsb indicated the database engine postgresql was in error since "2016-10-12 20:02:22 gmt".The same postgresql error was reproduced in house by removing the access rights on the folder d:\programs.The investigation found that this myla® server was used under "data analytics" project managed by us subs.The customer has agreed to be a pilot site for the "data analytics" project of the us subs.Us it teams made some changes on the myla® server for project needs.One change was done on d: drive ntfs permission in order to be able to remotely download csv files extracted daily from the server.The modification done by the subs on 12oct2016 caused the myla® crash due to database engine errors.Immediate action: this modification was removed by support teams activities on 14oct2016.So the customer myla® server was recovered in the validated state.Root cause: since initial installation, myla® server was no more in a validated state, because d: drive ntfs permissions were changed for local "data analytics" project.Human error.

• Brand Name: MYLA SERVER HP DL 380
• Type of Device: MYLA SERVER HP DL 380
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6095556
• MDR Text Key: 59871270
• Report Number: 3002769706-2016-00471
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL I, EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

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: 415603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1