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

Model Number 410417

Device Problems Computer Software Problem (1112); Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) initially reported to biomérieux that they have observed a software lockup with vidas® analyzer (ref.410417, serial number (b)(4)), which lead to indirect harm for one patient.The customer reported that a number of samples (total of 5) were listed as completed in the software but not released in the section (result was not generated either).This issue was fixed, but one of the samples was a serum sample from a neonate which could not be re-run.This resulted in a new blood sampling from the neonate, which is being considered as an unnecessary medical procedure.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was performed following notification from a customer from united-kingdom that they observed a software lockup with vidas® analyzer (ref.(b)(4), serial number ivd (b)(6)), which lead to indirect harm for one patient.Investigation the investigation for this issue is based on the vidas pc system logs provided by the field service engineer (fse).With the data backup, eight (8) days of logs were received, from (b)(6) 2021 to (b)(6) 2021.In the logs of (b)(6) 2021 (date of the issue), the following actions performed on the instrument can be checked: - start of the instrument at 09:22:43.- first runs with reported results ((b)(4) tests) from 10:26:18 to 12:36:38.- second runs with no reported results ((b)(4) tests) from 12:23:26 to 12:36:38.- restart of the instrument while the second runs are still in progress (a run is around 30 minutes by section in the case investigated) at 12:43:44.- reset of the 5 sections of the instrument corresponding to the intervention of the biomérieux fse to unlock the customer from 15:07:32 to 15:07:38 - third runs with reported results ((b)(4)tests): from 15:09:23 to 16:03:38 root cause of the issue: the root cause of the issue is the restart of the instrument while the second runs were still in progress.The runs of all sections were stopped and the corresponding results were never reported to the user software (usw).In that case, the planned ending time, which is displayed for each section in the usw, stays displayed even when the hour is over.As the instrument is restarted, each led at the top of each section stays unlit as the instrument is ready to work, instead of having each led blinking green to show that the corresponding section has finished the run.This is why the customer reported that a number of samples (total of (b)(4)) were listed as completed in the software but not released in the section; corresponding results were not reported either in the user software.Conclusion: the investigation showed that the root cause of the issue is a restart of the instrument during the second runs of the date of customer issue, with the impact of (b)(4) tests which did not have their result reported to the user software.The issue has been detected once over the 8 days of logs provided from this instrument.The issue is already traced in the vidas risk analysis.This risk is assessed as irrelevant after mitigation.The vidas user manual does contain a warning of this issue.For this customer¿s issue, it is not possible to know for sure what was the origin of this restart of the instrument.The recommendation of biomérieux was provided: - first, to check the power supply connection of the instrument and to replace the power supply connector.- second, to replace the power supply unit in case the issue is reproduced after the first check and replacement.

Manufacturer Narrative

Product code ¿dew¿ was assigned to the registration k891385 for the vidas® analyzer.This submission is to correct the product code ¿dew' and update to the appropriate code 'jje' per fda request.

• Brand Name: VIDAS® ANALYZER
• Type of Device: VIDAS® ANALYZER
• 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: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12675371
• MDR Text Key: 277743480
• Report Number: 9615037-2021-00012
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K891385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 410417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention