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
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 kingdom complained after having obtained what they described as potential incorrect identification test results when using their vitek ms prime system.The customer said that in some instances they were unable to get a correct identification test result.The customer mentioned they had obtained "no identification" test results in many cases.No further details were available at the time of this assessment.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
Following the potential incorrect identification test results reported by the customer when using their vitek ms prime system an investigation has been carried out at biomérieux manufacturing site.The customer provided a list of samples for which they had obtained "no identification" results.The samples mzml files provided are not in agreement with the identifications provided.Consequently, these identifications results could not be analyzed.The customer said that for one sample the expected identification was tsukamurella spp however no reference method was used to confirm the expected identification.Tsukamurella spp is present in the vitek ms kb v3.2 knowledge base.Culture conditions were checked and found to be aligned with biomérieux recommandations'.Complaint trend analysis and device history record was perfomed and no general trend has been identified.There is no capa, nor non conformity on vitek ms linked with customer 's complaint according to the vilink alert tool criteria, an aft was needed during the customer¿s tests the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Based on the analysis done with calibrator mzml files, the identification issue could be link to a non-optimal spot preparation of the strains and to a fine tuning that has drifted under the vilink alert tool criteria customer training materials was provided to the customer to help him to improve his spot preparation technique.

• Brand Name: VITEK® MS PRIME
• Common Device Name: VITEK® MS PRIME
• Manufacturer (Section D): BIOMÉRIEUX SA; biomérieux sa; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; 38390 ; FR 38390
• Manufacturer Contact: stefania ciranda ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16813579
• Report Number: 9615754-2023-00027
• Device Sequence Number: 5780938
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/10/2023

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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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