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

Model Number	423281
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product description: 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.The vitek® ms prime system is intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Complaint description: a customer in the united states complained after having obtained what they described as a potential incorrect identification test result.The customer said that they had tested a microorganism using their vitek ms prime system and that it was identified as streptococcus pneumoniae.The customer states that the identification result is incorrect.No further details were available at the time of this assessment.The customer vitek ms prime data were reprocessed by biomérieux global customer service (gcs).Based on preliminary findings, the organism could be a streptococcus infantis or a streptococcus peroris or another streptococcus species.Gcs requested the submission of the concerned strain for further testing.There is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of a patient.
Additional Manufacturer Narrative
An investigation was completed in response to this customer complaint of obtaining a potential incorrect identification test result when using vitek® ms prime (ref (b)(4), serial (b)(4)).1.Complaint trend analysis and device history record: the review of the worldwide complaint database was performed from december 2022 to february 2023 for the error code ivd mis-identification - f871 and no general trend was identified.2.Investigation: *fine tuning.According to the vilink alert tool criteria, no fine tuning was needed on vitek ms prime during the tests made on 28 feb 2023.*spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.*knowledge base (kb) review: the expected identification is unknown, no reference method has been made to confirm the expected identification.*sample data analysis: reprocessing of vitek ms prime data with vitek ms kb v3.2 allows to obtain four potential misidentification to streptococcus pneumoniae.These results were obtained with correct amount of peaks (between 69 to 106) and correct scores (except one which is slightly negative, -0.03).The same strain tested with vitek ms allows to obtain two "no identification".Reprocessing of vitek ms prime data with new vitek ms kb v3.3 allows to obtain low discrimination to streptococcus peroris - streptococcus pneumoniae for 3 out of 4 tests made.And reprocessing of vitek ms data with new vitek ms kb v3.3 allows to obtain single choice to streptococcus peroris for both spectra.These results were obtained with low scores meaning that it could be another streptococcus species.Reprocessing of vitek ms prime data with ruo database (saramis v4.17) allows to obtain streptococcus spp for 3 out of 4 tests made.And reprocessing of vitek ms data with ruo database (saramis v4.17) allows to obtain low discrimination to streptococcus infantis - streptococcus pneumoniae for both spectra based on all these findings, the cause of the misidentification issue could be linked to a system limitation (species out of the vitek ms kb v3.2).Based on vitek ms kb v3.3 and ruo saramis 4.17, it could be a streptococcus infantis or a streptococcus peroris or another streptococcus species.To try to confirm the cause of the identification issues, a strain return has been asked.Unfortunately, the customer cannot provide us the strain.Consequently, no further investigation could be done.For information: -there is the following system limitation in the user manual supplements -161150-1618-b - en - vitek ms prime v3.2kb - clinical use - us: * 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.-our r&d department had recorded a change request (#2445) in order to improve the future vitek ms knowledge base for streptococcus species.*expected identification after investigation: unknown.3.Root cause analysis: unknown as no further investigation on the strain is possible to confirm the strain identification.

• Brand Name: VITEK MS PRIME - 423281
• Common Device Name: 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: stefania ciranda ; 5 rue des aqueducs; craponne
• MDR Report Key: 16644753
• Report Number: 9615754-2023-00022
• Device Sequence Number: 12141611
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: 423281
• Device Catalogue Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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