MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 BLUE MODULE COLORIMETRIC; VITEK® 2 XL

Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of delayed results when using the vitek® 2 system (ref 27227).Vitek 2 cards were remaining in the preliminary phase with no results being provided.The vitek 2 system was stuck in the initializing process so the instrument was restarted remotely, but the cards that had remained in the preliminary phase were terminated.The cards required repeat testing.There was a power interruption overnight, but the system is plugged into a ups and the hospital's emergency power supply.The customer stated there was a delay in reporting results of greater than 24 hours due to the instrument issue.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from (b)(6) notified biomérieux of delayed results when using the vitek® 2 system (ref 27227).The customer indicated that the site had a power interruption overnight after test cards were loaded.The system was connected to a ups and a power conditioner, but it was not confirmed that the vitek 2 was connected to the hospital emergency power.An instrument failure message was observed when the system was rebooted.The customer reported that more than 30 cards remained at the prelim state and later terminated with no results.The requested instrument log files containing the date of the event were not provided.Without the associated instrument and software logs showing detail leading up to the reported event, it is not possible to determine what occurred.The vitek 2 system ups will maintain instrument power for approximately 20 minutes.For power interruptions that exceed this limit, the system will cease reading cards.Following the power failure (unknown duration) and upon successful reboot, it is likely the test cards terminated and ejected due to the time delay between test card readings.This is by design.If test cards are delayed greater than 40 minutes between readings, the test cards will terminate due to insufficient data to provide an accurate result.There is no evidence to suggest the vitek 2 instrument performed outside defined parameters.

• Brand Name: VITEK® 2 BLUE MODULE COLORIMETRIC
• Common Device Name: VITEK® 2 XL
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8203955
• Report Number: 1950204-2018-00731
• Device Sequence Number: 18884850
• Product Code: LON
• UDI-Device Identifier: 03573026162375
• UDI-Public: 03573026162375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N50510: S146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1