MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK® MS INSTRUMENT

Model Number 410895

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

Intended use: vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.Issue description.A customer in norway notified biomérieux of results delayed more than 24h in association with the vitek ms instrument (ref.410895, serial number (b)(4)).Customer reported having delayed results more than 24h, but at the time of the global assesment they did not answer if patient treatment was affected by the delay.A fine tuning was planned and performed and the system is operational.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation will be opened.

Manufacturer Narrative

Context: a customer in norway notified biomérieux that the system was not able to get results all over the weekend (25 and 26mar2023) because of bad performances on the system vitek ms instrument (ref.410895, serial number (b)(6)).The customer stated that the problem has created a result delay of up to 24 hours.No formal data was provided about a possible patient problem since the issue.Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results.Investigation protocol and data/sample provided: complaint handling process data : no formal data was provided by the customer.Findings: an investigation has been created for this complaint because this issue is reported to competent authority.Data have been requested to investigate on the 27mar2023.On the 31mar2023 a reminder was performed by the local customer service but no formal data or info were provided by the customer.On the 15may2023 a reminder was performed by the local customer service: the customer answer was: on saturday 25mar2023, they discovered that the system got bad performances again despite the last fine tuning achieved the 17mar2023: on monday: (b)(6) 2023, the sample identification of 2 patients with positive blood cultures were delayed by a few hours due to the new finetuning performed all types of sample were delayed by 4-5 hours.But no patient impact was identified.Investigation about performance of the system : according to the fine-tuning technical data provided by local customer service: on the 17mar2023 : the identification drifted performance was identified and the system was realigned following the requirements : vitek ms settings : lp 96 /ld 2490 / to 0.025.The values from the finetuning analyzer shows that the tuning meets all criteria.Median number of peaks: 119.0 for a minimum of 100.Median number of "good" peaks: 64.5 for a minimum of 50.Ratio median of good peaks vs median of bad peaks: 3.91 for a minimum of 3.50.Presence of mass 7872 da: 100 % for a minimum of 90.Presence of mass 6856 da: 100 % for a minimum of 60.Presence of mass 10300 da: 100 % for a minimum of 90.Presence of mass 11450 da: 83 % for a minimum of 50.On the 27mar2023 a corrective fine tuning was done : vitek ms settings : lp96 / ld2500 / to 0.015.The values from the finetuning analyzer shows that the tuning meets all criteria again median number of peaks: 119.0 for a minimum of 100.Median number of "good" peaks: 64.0 for a minimum of 50.Ratio median of good peaks vs median of bad peaks: 4.27 for a minimum of 3.50.Presence of mass 7872 da: 100 % for a minimum of 90.Presence of mass 6856 da: 100 % for a minimum of 60.Presence of mass 10300 da: 100 % for a minimum of 90.Presence of mass 11450 da: 100 % for a minimum of 50.There was no significative difference about these two fine tunings only the threshold detection offset.The threshold offset in used to adjust the peaks detection level capability of the system.This parameter is affected by the sample preparation made by customers.We can conclude that the sample preparation done on the 17may2023 was not optimal.No formal data was provided by the customer since the issue and reminders consequently, based on the rules for closure of the procedure 026816 rev.18.A decision was made to close the investigation due to impossibility to investigate deeper conclusion: based on the limited information provided, the issue could be related to the difference in sample preparation performed by the customer for the fine-tuning slide and routine slides, as well as a lack of ft monitoring.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16673547
• MDR Text Key: 312979992
• Report Number: 9615754-2023-00024
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K181412
• 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
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1