MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A VIDAS® ANALYZER [U]

Model Number	99735U
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product description: the vidas® system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for in vitro diagnostic (ivd) purpose, veterinary and industrial applications.The vidas® system is intended to execute an immunoassay protocol and to release results according to the package insert of the vidas® assay kits.Issue description: on (b)(6) 2026, a customer from mexico notified biomérieux of obtaining potential false results when using vidas analyzer [u] (ref.99735u, serial number: (b)(6)).The customer reported obtaining questionable results for t4 and tsh with vidas analyzer [u] (ref.99735u, serial number: (b)(6)).T4 generated values above 320, and tsh also presented irregular results; after reprocessing, tsh produced values around ¿0.6.The same tests were performed on the vidas kube, where consistent and reliable results were obtained.Additionally, certain d dimer measurements exceeded 4000.Troponin results were 2.5 on the first measurement and 3.7 on the second for a patient diagnosed with myocardial infarction.The vidas reports and the number of impacted sample were not provided.The customer indicated that preventive maintenance of vidas analyzer [u] (ref.99735u, serial number: (b)(6)) had recently been performed on (b)(6) 2026.A full functional inspection of the instrument was performed.The optical system value was found to be below the recommended threshold, and the opt test showed deviated readings.An optical system adjustment was completed.Subsequent opt tests and quality control verification (qcv) tests were performed, producing results within expectations.The issue was resolved.According to the customer, no delays or therapeutic errors occurred, as they were able to verify results using their vidas kube system.A biomérieux internal investigation will be initiated.

• Brand Name: VIDAS® ANALYZER [U]
• Common Device Name: VIDAS® ANALYZER [U]
• Manufacturer (Section D): BIOMERIEUX 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: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 24568515
• Report Number: 9615037-2026-00002
• Device Sequence Number: 15542567
• Product Code: JJE
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K891385
• 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): 04/27/2026

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: 99735U
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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