MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 XL BLUE MOD COLORM 220V

Model Number 27228

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported an issue with the pipettor in association with the vitek® 2 xl blue mod colorm 220v.A biomérieux field service engineer (fse) was on site and reviewed the vitek® 2 xl instrument flash logs showing network errors for node 5 (pipettor).The fse replaced the prep node printed circuit board (spn pcb) which did not resolve the issue.The dc power supply board (dcbob) was replaced and upgraded to the version with individual cables for each sample prep node board (spn), but the issue was not resolved.The bay controller board (bcb) was replaced and the error was the same.The system was powered up and the log reported node 9 errors.After a few minutes the fse smelled smoke and observed a flame coming from u49 on the bcb and immediately powered the system down.The old bcb and u49 showed the chip had some signs of damage.There was no patient testing involved with the vitek® 2 xl instrument event.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

During the service visit by the field service engineer (fse), the bcb was replaced, and after a few minutes, the fse observed smoke from the u49 chip on the bcb.An investigation was performed.The following parts were returned for this investigation: a 1x bcb pcba (9309161), 2x bcb pcba (6204050), 2x dc bob (530748-924), 9x gspb pcba (6204040), 1x fspn pcba (6200932).After inspecting field returned pcbas and being bench tested, the investigator concluded that pcbas were damaged during troubleshooting at the job site, due to electrical connection issue induced by fse.Mosfet (q1) failure on a spn pcba (incubator-a) and u49 failure on bcb pcbas are not typical failure modes.These failures were most likely caused by improper connection, improper grounding or electrical short during re-wiring pcbas.There was no fire associated with the spn or bcb pcbas that were damaged during troubleshooting.There was no danger to the operator or instrument as individual pcba was no longer functional following component failure.

• Brand Name: VITEK® 2 XL BLUE MOD COLORM 220V
• Type of Device: VITEK® 2 XL BLUE MOD COLORM 220V
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6745281
• MDR Text Key: 81111525
• Report Number: 1950204-2017-00239
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27228
• Other Device ID Number: 03573026162382
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1