MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 COMPACT INSTRUMENT

Model Number W0452

Device Problems Failure to Back-Up (1047); Data Back-Up Problem (2902)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of an internal system error after performing a manual back-up of the vitek® pc (reference (b)(4)) associated with vitek® 2 compact instrument.The customer reported a manual back-up was performed because the end of day back-up was not available.No information was provided regarding if there was any user or patient impact.The customer indicated that all cards had to be setup again which caused a delay greater than 24 hours.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An investigation was performed in response to a backup failure observed on one of the vitek 2 systems pcs at the customer site, and was followed by an internal system error (ise).Local customer service (lcs) recommended restoring data backups from a previous day.Results from cards originally tested on (b)(6) 2018 were not available, and testing had to be repeated.A review of the logs provided from the dates of occurrences of (b)(6) 2018 indicate that the cause of the problem is an invalid certificate setup causing communication failures to the biomérieux user management service for the purposes of card processing, endofday and manual backups and restores.The impact of not having the system in a proper controlled/validated state can be as simple as minor errors, to inability to login, to loss of card data - depending on the usage of the system in the improper state.It is recommended that sites be properly setup by running the certificate setup scripts for the applicable setup type as indicated in the system setup guides.And that sites be notified that modifying the system in ways such as changing the pc name or modifying the network configuration can cause the certificates to become invalid.

• Brand Name: VITEK® 2 COMPACT INSTRUMENT
• Type of Device: VITEK® 2 COMPACT INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: tiffany hall ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7746677
• MDR Text Key: 115914217
• Report Number: 1950204-2018-00279
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W0452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1