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

Model Number	412590
Medical Device Problem Codes	Pumping Problem (3016); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 27-may-2025, a customer in france notified biomérieux of possible erroneous patient results tested in position b1 of their vidas® 3 instrument (ref.412590, serial no.(b)(6)).The customer noticed overestimated results on position b1 of their vidas.A field service engineer (fse) intervention has been planned to solve the issue.The customer performed an impact study for potential false results that have been performed and communicated to the clinicians.The customer identified samples tested with havt, gdh, and cdab kits.The samples performed during this period on this b1 position: havt: 15 patients, gdh: 19 patients, cdab: 4 patients.The customer already retested all patients for havt and eight (8) patient samples had an interpretation change from positive to negative.As for the other samples, retesting could not be performed because samples were no longer available.Havt results: concentration - interpretation, < 15 miu/ml - negative, > 15 and < 20 miu/ml - borderline positive, > 20 miu/ml ¿ positive.Sample id/initial interpretation/new result patient 3 (b)(6) /positive 48/negative <15.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in france regarding possible erroneous patient results tested in position b1 of their vidas® 3 instrument.Ref.412590, serial no.(b)(6).A biomérieux internal investigation has been completed with the following results: 1.Immediate actions done.Retrospectives analyses done.The local customer service (lcs) investigated directly on site and decided to replace the pump of instrument section b.2.Investigation.The investigation was performed based on the information communicated by the customer and by the field service engineer (fse).Unfortunately, there was no possibility to investigate directly on the defective pump as it was scrapped after replacement.The fse replaced pump of section b according to the procedure, checked alignments, updated firmware.After those actions, qualification test (fot) passed and system is operating as per specifications.3.Conclusion.The actions taken by the fse solved the issue linked to the pump on the customer's site.Despite all the actions performed during the investigation, the root cause of the complained issue was not determined.Due to the impossibility to test the pump, the complained problem has not been reproduced.

• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 22146177
• Report Number: 9615037-2025-00011
• Device Sequence Number: 15552074
• Product Code: JJE
• UDI-Device Identifier: 03573026380175
• UDI-Public: 03573026380175
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/07/2025

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 Model Number: 412590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 11/07/2025
• 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