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

Catalog Number	412590
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 20-aug-2024, a customer from chinese taipei notified biomérieux of obtaining overestimated result when testing patient with vidas® d-dimer exclusion ii (ref.30455) in vidas 3 instrument (ref.412590, serial number: (b)(6).The customer analyzed patient sample with vidas® d-dimer exclusion ii (ref.30455) in vidas 3 instrument (ref.412590, serial number: (b)(6), software version: v1.4.0) with the ¿load and go¿ mode and obtained the following results: when the test is performed in the same section with vidas® nt-probnp2 test: 480 ng/ml when the test is performed without any other test in the section: 212 ng/ml according to vidas assay compatibility information, the vidas® d-dimer exclusion ii (ref.30455) and vidas® nt-probnp2 tests could not be processed in the same section because the protocols are different.And in this case, no alarm was triggered by vidas 3 instrument (ref.412590, serial number: (b)(6), software version: v1.4.0).Based on the available information at the time of this assessment, there is no data available regarding a potential patient¿s impact of this issue, or any delayed of results.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was initiated following notification from a customer in china taipei of obtaining overestimated result when testing patient with vidas® d-dimer exclusion ii (ref.30455) on vidas 3 instrument (ref.412590, serial number: (b)(6), software version: 1.4.0).The investigation confirmed that vidas® 3 software version 1.4.0 / 1.4.1 / 1.4.2 / 1.4.3 in "load and go" mode does not check the compatibility of protocols for tests run in the same section.This issue occurred only with vidas® 3 instrument (ref.412590 / 412590u / 412590r) with software versions 1.4.0 / 1.4.1 / 1.4.2 / 1.4.3 in "load and go".The issue is not present in vidas® 3 software version 1.3 and below.The issue is not present when the analysis is launched with the standard mode (analysis created before loading the strip and spr).The issue does not occur if there is other type of error on the section (for example missing calibration, strip already loaded, number of readings by the scanner head on the instrument on the sample is different between analysis in the section.).If there is no other error (like calibration, incorrect spr or strip.), the protocol of the strip on the first position will be used for all the strips even if the protocols are not the same, then results are delivered for all assays.4.Conclusion the investigation confirmed that the protocol compatibility is not verified when several analyses are launched on the same section using the "load and go" mode.Biomérieux assessed the risk associated with this issue and determined that the overall risk is irrelevant.A new software version 1.4.4 is developed to fix this issue and will be released in q4 2024.Until the new software version 1.4.4 is installed, it is recommended to continue to use the "load and go" mode with only one vidas parameter in the same section.

• 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: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 20134302
• Report Number: 9615037-2024-00024
• Device Sequence Number: 17947302
• Product Code: JJE
• UDI-Device Identifier: 03573026380175
• UDI-Public: 03573026380175
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/20/2024

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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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