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

Model Number 423281

Device Problem Incorrect Measurement (1383)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Intended use: vitek® ms prime 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 prime 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 and fungal infections.Issue description: a customer in france reported to biomérieux potential misidentifications of streptococcus mitis/oralis as streptococus pneumoniae, moraxella catarrhalis and rothia mucilaginosa while using vitek ms prime (ref.423281, serial number unknown).It was reported that customer received no identification (id) results and misidentifications with five (5) isolates (numbers h2362082-1 / -2 / -3 / -4 / -5) compared to vitek 2 gp identification and optochin test results.It was confirmed that the five (5) isolates were from the same patient who was a 9 week old child with medical history of pyelonephritis.The results obtained with vitek ms prime (mentioned in lab reports provided by customer) were as follows: isolate h2362082-1: results validated.(b)(6) 2023: result 1 = no id; result 2 = streptococus pneumoniae (97.9%); result 3 = no id ; result 4 = streptococus pneumoniae (66.5%).(b)(6) 2023: result 5 = streptococus pneumoniae (99.3%).(b)(6) 2023: result 6 = no id; result 7 = no id; result 8 = no id; result 9 = no id; result 10 = streptococus pneumoniae (90.7%); result 11 = no id.(b)(6) 2023: result 12 = streptococus pneumoniae (47.6%); result 13 = streptococus suis (52.4%).(b)(6) 2023: result 14 = streptococus pneumoniae (99.5%).Isolate h2362082-2: results rejected.(b)(6) 2023: result = no id.(b)(6) 2023: result = moraxella catarrhalis (99.9%).(b)(6) 2023: result = rohia mucilaginosa (99.9%).Isolate h2362082-3: results rejected.(b)(6) 2023: result = no id.Isolate h2362082-4: results rejected.(b)(6) 2023: result = no id.Isolate h2362082-5: results rejected.(b)(6) 2023: result = streptococus pneumoniae (99.9%).Final identification: streptococcus mitis/oralis (vitek 2 id gp + optochin resistant).According to available information at the time of the global assessment, it was reported that the patient impact was the performance of a lumbar puncture following isolation of streptococcus pneumoniae; no problem of treatment the patient having in addition a pyelonephritis treated by ceftriaxone.It is understood that the medical intervention (lumbar puncture) has been performed based on the result provided by vitek ms prime.An investigation has been initiated.

Manufacturer Narrative

Context: a customer in france reported to biomérieux potential misidentifications of streptococcus mitis/oralis as streptococus pneumoniae, moraxella catarrhalis and rothia mucilaginosa while using vitek ms prime (ref.423281, serial number (b)(6)).Vitek ms mode: ivd.Kb version: 3.2 (cli).Issue type: misidentification to streptococcus pneumoniae, moraxella catarrhalis and rothia mucilaginosa instead of streptococcus mitis/oralis for the same sample (the isolates numbers h2362082-1 / -2 / -3 / -4 / -5).Vitek ms results: no identification (9 times).Single choice to streptococcus pneumoniae (6 times).Single choice to rothia mucilaginosa (2 times).Single choice to moraxella (branhamella) catarrhalis (1 time).Low discrimination to streptococcus suis.Streptococcus pneumoniae (1 time).Other methods: vitek gp card = streptococcus mitis/oralis.Optochin test = resistant which not in favor to streptococcus pneumoniae.Expected id: unknown, no reference method has been made to confirm the expected identification.Culture conditions: culture media: horse blood agar under 5% co2.Incubation: different ages of culture, from 4h to 24h.Spotting tool: unknown.Issue date: 15, 16, 17, 18 and 19 apr 2023.Auto fine tuning date before the issue: 02 jan 2023 and 18 apr 2023.Investigation: batch history record and complaint trend analysis: there is no capa, no non-conformity on vitek ms prime linked with customer's complaint.A trend analysis has been for the period from may 2023 to july 2023 with the error code ivd mis-identification - f871; no trend has been identified.Investigation results: fine tuning.According to the vilink alert tool criteria, no fine tuning was needed on vitek ms prime during customer¿s tests.The spot preparation seems to be good.Analysis of the pictures of spots did not allow to highlight any sample preparation issue.Kb review : unknown, no reference method has been made to confirm the expected identifications.However, streptococcus mitis/oralis is present in the vitek ms prime kb v3.2.Sample data analysis: reprocessing of the data with vitek ms kb v3.2 allows to obtained heterogeneous results.The amount of no identification is quite high (9 out of 19 tests) meaning that it could be a species out of the knowledge base.Reprocessing of the customer¿s data with new vitek ms kb v3.3 also allows to obtained heterogeneous results and several identification streptococcus peroris which in not present in knowledge base v3.2.Biomérieux quality control laboratory did not reproduce the identifications issues obtained by the customer to streptococcus pneumoniae, moraxella catarrhalis and rothia mucilaginosa with their vitek ms and vitek ms prime but obtained identification as streptococcus mitis/streptococcus oralis or no identification or low discrimination.According to biomérieux quality control results, decision was made to perform a sequencing of the strain to confirm the identification.The strain was then identified as streptococcus infantis/streptococcus peroris based on soda sequence analysis, the sequence of the strain is a little bit short (391 bp) and the homology percentage is quite low to conclude to the species level.Both species don't belong to vitek-ms database (kb3.2), which could explain the various results obtained with both system.For information, streptococcus infantis and streptococcus peroris have been added to kb v3.3 and r&d department had recorded a change request (#2445) to improve the future vitek ms knowledge base for streptococcus species.There is the following system limitation in the user manual supplements - 161150-1611 - b - en - vitek ms prime clinical use - v3.2 knowledge base: interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ testing of species not found in the database may result in an unidentified result or a misidentification.Expected identification after investigation: streptococcus infantis/streptococcus peroris.Conclusion: the most probable root cause of this issue is a system limitation (species out of the knowledge base v3.2).According to data above, there is no reconsideration of vitek ms prime (ref.423281) performance.

• Brand Name: VITEK® MS PRIME
• 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): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16852324
• MDR Text Key: 314411534
• Report Number: 9615754-2023-00028
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/20/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/11/2023
• 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
• Patient Age: 9 WK