MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS PRIME - 423281

Model Number 423281

Device Problem Incorrect Measurement (1383)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

Intended use: the vitek® ms system, reference (b)(4), is a mass spectrometer using maldi-tof (matrix-assisted laser desorption/ionization-time of flight) technology for the identification of microorganisms cultured from clinical specimens.Description of the issue: a customer in malaysia notified biomerieux of obtaining discrepant identification results.Between vitek ms prime reference (b)(4) ( serial number : (b)(4)) and vitek ms legacy and between vitek ms prime reference (b)(4) ( serial number : (b)(4)) & vitek 2 ( lot not specified).Summary: isolate 1.Vitek ms prime aeromonas sobria/veronii.Vitek ms legacy : aeromonas hydrophila 99.9%.Vitek 2 gn :aeromonas hydrophila 98%.Isolate 2.Vitek ms prime aeromonas sobria/veronii.Vitek 2 aeromonas hydrophila 98%.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.This discrepancy was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.Biomérieux internal standard operational procedures states that erroneous test results could result in a lack of appropriate diagnosis or therapy, continued administration of inappropriate antimicrobials, or other potentially toxic therapies.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context.A customer in malaysia notified biomerieux of obtaining discrepant identification results between vitek ms prime reference (b)(4) ( serial number : (b)(6)) and vitek ms legacy and between vitek ms prime reference (b)(4) ( serial number : (b)(6)) & vitek 2 ( lot not specified) investigation results.Fine tuning.Vitek ms prime : according to the vilink alert tool criteria, an auto fine tuning was needed during the tests made in december 2022 and january 2023.An aft is required.Vitek ms : due to lack of data, it is not possible to evaluate the fine tuning status during the customer¿s tests.However, the fine tuning made prior to the identification issue was conform.Spot preparation quality.The calibrator ¿all peaks¿ values are quite heterogeneous.Knowledge base review.Aeromonas hydrophila, aeromonas sobria, aeromonas veronii are present in vitek ms kb v3.2 sample data analysis.Reprocessing the isolate 1 data with vitek ms kb v3.2 allows to show that the potential misidentification to aeromonas sobria/veronii was obtained with a good amount of peaks (72) and acceptable scores.Reprocessing the customer data with new vitek ms kb v3.3 allows to identify the sample to aeromonas dhakensis.This species is not present in vitek ms kb v3.2 reprocessing the isolate 2 data with vitek ms kb v3.2 allows to show that the potential misidentification to aeromonas sobria/veronii was obtained with a good amount of peaks (56) and acceptable scores reprocessing the customer data with next vitek ms kb v3.3 allows to identify the sample to aeromonas veronii.Aeromonas sobria and aeromonas veronii are identified as single choice in the next vitek ms kb v3.3 analysis of the submitted strains.Vitek ms.Isolate (b)(4) : five low discrimination to aeromonas sobria - aeromonas veronii isolate (b)(4) : five single choice to aeromonas hydrophila vitek ms prime.Isolate (b)(4) : five low discrimination to aeromonas sobria - aeromonas veronii isolate (b)(4) : three low discrimination to aeromonas sobria - aeromonas veronii and two no identification results based on these results, the customer issue is confirmed with vitek ms kb v3.2, results are not similar between vitek ms and vitek ms prime for one out of the two isolates tested.In addition, biomérieux quality control laboratory data have been reprocessed with new vitek ms kb v3.3 and it gave the following results: vitek ms.Isolate (b)(4) : five single choice to aeromonas veronii isolate (b)(4) : five single choice aeromonas dhakensis vitek ms prime.Isolate (b)(4) : five single choice to aeromonas veronii isolate (b)(4) : five single choice aeromonas dhakensis based on these results, the customer issue is fixed with new vitek ms v3.3.The results are homogeneous and similar between vitek ms and vitek ms prime.The most probable identifications are aeromonas veronii for isolate (b)(4) and aeromonas dhakensis for isolate (b)(4).Reference method testing.Based on gyrb sequencing, the strain (b)(4) is identified as aeromonas veronii and the strain (b)(4) is identified as aeromonas dhakensis, which was previously a subspecies of aeromonas hydrophila.The gyrb sequencing results confirmed that the customer issue is fixed with new vitek ms v3.3.The results are homogeneous and similar between vitek ms and vitek ms prime.The identifications are aeromonas veronii for isolate (b)(4) and aeromonas dhakensis for isolate (b)(4).Conclusion.The issue has been reproduced during in site testing and is due to a known system limitation which is fixed in the software version vitek ms v3.3.

• Brand Name: VITEK MS PRIME - 423281
• Type of Device: VITEK MS PRIME - 423281
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16022862
• MDR Text Key: 308155548
• Report Number: 9615754-2022-00149
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K212461
• 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: 05/11/2023

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: 423281
• Device Catalogue Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1