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

Catalog 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 10-nov-2023, a customer in france notified biomérieux of potential false positive patient results when using compartment d of vidas® 3 system reference (b)(4) (serial number (b)(6).This customer noticed that the results for position d1 were not identical with the other positions (this started with the c2 hiv control).Customer results: c2 hiv : 0.42 (positive) - 101 rfv - automatic - d1.0.09 (negative) - 22 rfv - manual - c1.Hiv patient : 0.48 (positive) - 115 rfv - automatic - d1.0.08 (negative) - 21 rfv - automatic - a1.Patient for vcam : 0.46 (positive) - 366 rfv - automatic - d1.0.06 (negative) - 50 rfv - manual - b1.The instrument logs analysis concluded that there was no problem identified.At the time of this assessment, there was no indication of patient harm, incorrect treatment, or delay.The wrong results have not been given to the physician.A biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer of false positive patient results when using compartment d of vidas® 3 system reference 412590 (serial number (b)(6)).1.Immediate actions done.Disconnect the section d.The wrong results have not been given to the physician.Data collection for investigation.The local customer service (lcs) investigated directly on site and decided to replace the pump of instrument section d.2.Investigation the investigation was performed based on the information communicated by the customer and the biomérieux field service engineer (fse).The instrument log files were reviewed, but there was no possibility to investigate directly on the instrument as the the pump that was replaced was not retained.2.1 investigation on site by the fse: the fse observed an issue on section d, the qualification test called functional and operational test (fot) was failed.Based on the test performed, it was decided to replace the pump of section d.This action solved the issue (fot result is passed.) 2.2 instrument logs analysis: this analysis shows that there is no issue on the instrument regarding: the temperatures of the sections; the pipettor; the scanner head; the section pump.Specifically, on the three (3) false-positive results reported, there was no difference compared to a typical analysis.A complaint analysis did not reveal this issue as a systemic quality issue.3.Conclusion the actions taken by the fse (replaced pump) solved the issue at the customer site.Despite all the actions performed during our investigation, biomérieux was not able to find the root cause of the complained issue.There was no possibility to test the pump in its original conditions and no other pump defect was identified.A retrospective analysis performed by the customer confirmed that no other result was impacted by the problem; the samples with false-positive results were successfully rerun on a different instrument section, therefore excluding any patient impact.As a result of the investigation, there is no reconsideration of the performance of vidas® 3 system reference (b)(4).

• 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: matt floretta ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 18235738
• Report Number: 9615037-2023-00015
• Device Sequence Number: 7160019
• 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): 01/19/2024

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 Catalogue 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: 11/10/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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