MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA S.P.A. VIDAS® 3

Catalog Number	412590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Product description the vidas® 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).The vidas® 3 system is intended to be used with vidas® reagents in clinical laboratories only.This device is an in vitro diagnostic medical device for professional use only.Issue description on (b)(6) 2024, a customer in the united states notified biomérieux of an instrument error when using vidas® 3 reference (b)(4) serial number (b)(6).The customer reported the vidas® 3 was "frozen".Biomérieux fse replaced numerous components until the system was able to communicate with itself.Replaced pipettor, pipettor board, loading bay, loading bay board, scanner, scanner board, scanner cable, power supply and smb.The system was then able to successfully pass all post service tests and checks.At the time of the assessment, there was no indication of patient harm or incorrect treatment.The customer did report a patient's pct result delay of 5 days due to the issue.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was initiated following notification from a customer in the united states of an instrument error when using vidas® 3 reference 412590, serial number (b)(6).1.Immediate actions done: field service engineer intervention.2.Investigation: during the support given by local biomérieux, the support team confirmed a problem with multiple sections as they were not available, as well as an error with the pipettor.After a restart, the fse confirmed that the instrument can't initialize correctly.During the troubleshooting performed by the fse, the vidas 3 initialization was blocked.After multiple components were replaced, the system was able to communicate and initialize as intended.3.Complaint analysis: there is no indication of a systemic quality issue with vidas® 3 reference 412590.4.Conclusion: the was no clear indication of the root cause of the issue.After multiple components were replaced.The instrument was able to initialize and operate as intended.There is no reconsideration of the performance of vidas® 3 reference (b)(4).

• Brand Name: VIDAS® 3
• Common Device Name: VIDAS® 3
• Manufacturer (Section D): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: matt floretta ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 19576969
• Report Number: 9615037-2024-00020
• Device Sequence Number: 19847835
• Product Code: JJE
• UDI-Device Identifier: 03573026380175
• UDI-Public: 03573026380175
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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
• Device Catalogue Number: 412590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown