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 mould infections.Issue description: a customer in sweden notified biomérieux of misidentification of micrococcus sp as bacillus cereus or pseudomonas aeruginosa in association with the vitek ms prime ref.(b)(4), serial number (b)(4).Customer has been testing their new vms prime in parallel with bruker.They had gram positive cocci from blood culture, which was processed 2 x 3 spots on vms prime.1st run: one id as bacillus cereus (61%) and "no id" in the other two spots.Slide: ds220618609.2nd run: one id as pseudomonas aeruginosa (83.1%) and "no id" in the other two spots.Slide: ds220618609.Bruker gave id to micrococcus sp., which fits the clinical data.There is no indication or report from the customer that this event led to any adverse event related to the patient's/user's state of health.An investigation has been opened.
Additional Manufacturer Narrative
Context: a customer in sweden notified biomérieux of misidentification of micrococcus sp as bacillus cereus or pseudomonas aeruginosa in association with the vitek ms prime (ref.(b)(4), serial number (b)(6).First run : single choice to bacillus cereus no identification (2 times).Second run : single choice to pseudomonas aeruginosa.No identification (2 times).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 fine tuning according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 2022.Spot preparation quality: the calibrator ¿all peaks¿ values are quite heterogeneous.Based on this finding, the spot preparation quality needs to be verifie.Knowledge base (kb) review: micrococcus spp seems to be the expected result from the microscopy; this is present in vitek ms kb v3.2 as it is at the genus level only.Sample data analysis reprocessing the customer data with vitek ms kb v3.2 allows to show that misidentification results were obtained with low identification scores (-0.39 and -0,34) which are near the acceptable limit for giving a ¿no identification¿ result (-0.4).When the spectra is reprocessed with mmass, a quite similar spectra was obtained.If it considers the most likely species, it is micrococcus luteus that returns most often.In saramis, no identification are given in superspectra and flavobacterium spp for spots e2, e3, k1 and k2.It is a system limitation, the species is mostly not present in any vitek ms kbs.The sample identification needs to be confirmed by a reference method.For information, the following system limitation is written in the user manual supplements - 161150-1611 ¿ b ¿ vitek ms prime clinical use - v3.2 knowledge base : testing of species not found in the database may result in an unidentified result or a misidentification.Note: 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.Expected identification after investigation: unknown.Conclusion: root cause is system limitation.

• 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: 15774166
• Report Number: 9615754-2022-00128
• Device Sequence Number: 19585665
• 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