MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS PRIME

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
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 mold infections.Issue description: a customer in sweden notified biomérieux of misidentification of staphylococcus hominis as citrobacter freundii in association with the vitek ms prime (b)(4).Customer has been testing their new vms prime in parallel with bruker.They had gram positive cocci from blood culture, which was identified as citrobacter freundii (93.7%) in 1 of 3 spots, and "no id" in the other 2 spots.Sample number: (b)(6), slide id: (b)(6).Bruker gave id staphylococcus hominis, which fits the clinical data.An investigation has been initiated.
Additional Manufacturer Narrative
A customer in sweden notified biomérieux of misidentification of staphylococcus hominis as citrobacter freundii in association with the vitek ms prime (ref.423281, serial number (b)(6)).Vitek ms prime: single choice to citrobacter freundii.No identification (2 times).Other methods : gram positive cocci (which is discordant with vitek ms results).Bruker (gave id staphylococcus hominis which fits the clinical data).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.Fine tuning according to the vilink alert tool criteria, no fine tuning was needed during the tests made on 31oct2022.Spot preparation quality the calibrator ¿all peaks¿ values are quite heterogeneous.Based on this finding, the spot preparation quality needs to be verified.Kb review staphylococcus hominis seems to be the expected results from the microscopy, this species is present in vitek ms kb v3.2.Sample data analysis reprocessing the customer data with vitek ms kb v3.2 allows to show that misidentification result was obtained with low identification scores (-0.25) which are near the acceptable limit for giving a ¿no identification¿ result (-0.4).This identification is obtained with the spectra which has the lowest number of peaks (46) which means this spectra is not one of a good quality.The sample ¿all peaks¿ values are heterogeneous.This could be explained by a non-optimal spot preparation of the calibrator strain (culture, spot, different operator, operator skills).It needs to be verified with the customer.By reprocessing the customer data with vitek ms kb v3.3 allows to remove the misidentification we have no more identification results.Saramis ssp 4.17 gives staphylococcus hominis and 2 no identification results.Saramis reference spectra 4.17 gives rather nocardia spp.With mmass, the spectra seems correct even if the c1 spots seem totally shifted compared to the others.If we degrade the thresholds on the scores and probabilities, we get well staphylococcus hominis as the most probable species, but the scores are at -0.41 with 92 peaks and -0.55.And if we set a maximum of 80 peaks for the 3 spectra, we have the c2 and c3 spots that actually come out well staphylococcus hominis.To try to find the cause of the identification issues, a strains return has been asked.Unfortunately, the customer cannot provide us the strain.Consequently, no further investigation could be done and the cause of the issue has been defined as ¿unknown¿.Expected identification after investigation unknown as strain return is not possible to confirm the identification root cause is unknown as further investigations on the strains are not possible.

• Brand Name: VITEK MS PRIME
• Common Device Name: VITEK MS PRIME
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3, route de port michaud; la balme les grottes 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3, route de port michaud; la balme les grottes 38390 ; FR 38390
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15773696
• Report Number: 9615754-2022-00127
• Device Sequence Number: 3010337
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K212461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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