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

Model Number	412590
Medical Device Problem Code	Failure to Sense (1559)
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) 2025, a customer from italy notified biomérieux of obtaining non-reproducible results when using vidas 3 - (ref.412590, serial number (b)(6).The customer realized a lack of repeatability because the values were not consistent with the patient's clinical situation while testing with vidas brhams pct.Subsequently, this lack of repeatability was only found in section a because, when repeating patients using the other sections, the values were consistent with the patients' clinical situation.The customer performed a retrospective analysis (from (b)(6) 2025 to today) and found that there were no other repeatability anomalies with other patients and that this issue had occurred in the last 5 patients.The results for the last five patients are the following: patient 1: at 11:45 am: 4.84 ng/ml on section a.Repetition at 5:27pm on section a: 0.85 ng/ml patient 2: at 9:18pm: 1.36 ng/ml on section a.Repetition at 9:19pm on section b: 0.17 ng/ml.Patient 3: at 3.49pm on section a: 5.9 ng/ml.First repletion at 4:34pm on section a: 41.94 ng/ml.Second repetition at 5:39pm on section c: <0.05 ng/ml.Patient 4: at 11:10am on section a: 33.09 ng/ml.Repetition at 11:57am on section a: 0.83 ng/ml.Patient 5: at 10:24am on section a: 12.67 ng/ml.Repetition at 12am: <0.05 ng/ml on section b.A field specialist engineer went on customer¿s site and changed the pump of the section a.After making some tests, he got conform values.On (b)(6) 2025, the customer tested new patient samples, and the results were conform to the patient¿s clinical status.The customer reported that there was no patient harm or incorrect treatment due to the referenced issue.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): BIOMERIEUX 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: 22751069
• Report Number: 9615037-2025-00030
• Device Sequence Number: 8715852
• Product Code: JJE
• UDI-Device Identifier: 03573026380175
• UDI-Public: 03573026380175
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 08/08/2025
• 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