MAUDE Adverse Event Report: bioMérieux Italia S.p.a VIDAS® 3 [R]

Model Number	412590R
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: VIDAS® 3 [R]
• Common Device Name: VIDAS® 3 [R]
• Manufacturer (Section D): bioMérieux Italia S.p.a; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): bioMérieux SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: emma cournoyer ; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 50721884
• Report Number: 9615037-2026-00008
• Device Sequence Number: 15589176
• Product Code: JJE
• UDI-Device Identifier: 03573026474317
• UDI-Public: 03573026474317
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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
• Report Date (Section B): 09/10/2026

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: 412590R
• 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: 07/09/2026
• Initial Report FDA Received Date: 09/10/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown