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

Model Number	412590
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: 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) 2026, a customer from france notified biomérieux of a pump issue that led to false results when using vidas 3 - (ref.412590, serial number (b)(6)).The customer noticed that there was an issue with the calibration made with the toxo igg parameter, which showed systematic discrepancies in position a2 with relative fluorescence value two times lower compared to other positions.The first invalid calibration occurred around (b)(6) 2026.A retrospective analysis of calibration and patient reports shown that up to 16 patients may have been affected across assays (ebna, cors, vcam, cmvm, cmvg, lym, lh and txg), all launched-on position a2.However, at the time of the assessment, no additional testing had been performed by the customer on these patient samples.As a result, there is no confirmation as to whether any of the 16 identified cases were indeed impacted.A field service engineer went to the customer place.The compartment a was deactived.Normal function was tested and all was clear.The sections were cleaned and checked.The pump in section a was replaced and the firmware was updated.The customer reported that there was no patient harm or incorrect treatment due to the referenced issue nor delay in rendering the results.A biomérieux internal investigation will be initiated.

• 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): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 25150581
• Report Number: 9615037-2026-00003
• Device Sequence Number: 15801826
• 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): 06/08/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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