MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK® MS PRIME

Model Number	423281
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
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: vitek® ms prime has not yet been sold in the united states; however, it is a similar product to the vitek® ms (ref.410895).A customer in (b)(6) notified biomérieux of misidentification of staphylococcus aureus as gardnerella vaginalis, and e.Coli as pseudomonas aeruginosa in association with vitek ms prime (ref.423281, serial number.(b)(4).The customer also obtained the expected identifications with vitek ms using the same slide.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 initiated.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in spain that they obtained discrepant results between vitek® ms prime and vitek® ms for thirteen (13) samples.The expected identification of each sample remains unknown as no reference method (i.E.Sequencing) was performed to confirm.The customer made no allegations of patient or operator death, patient or operator harm, nor was any patient treated incorrectly.Investigation: complaint analysis and device history record review: this review did not reveal evidence that the reported issue is a systemic quality problem.Fine tuning: during the customer study, three different systems were used for the tests performed between (b)(6) 2022.The fine tuning status of the vitek ms prime® and vitek ms® (serial# (b)(6)) was good at the time of the tests.However, vitek ms® (serial# (b)(6)) status was ¿low¿, indicating that fine tuning was needed at the time of the tests.In cases like this, fine tuning status analysis may not be relevant because all prerequisites were not met for monitoring the system.Spot preparation quality: the calibrator and sample ¿all peaks¿ values are heterogeneous; a sign that spot preparation by the user was not optimal.Customer data analysis: per the customer¿s statements, they incubated the samples on plates for three (3) hours before depositing them onto the slides.Per instructions for use (ifu), the recommended incubation time is 18-72 hours.The customer¿s incubation of three hours is considered off-label use.Short incubation time could affect bacteria protein expression, as well as culture growth (may be not sufficient to properly collect organisms on the plate).Conclusion: the customer is currently using the system in an ¿off label¿ manner.This could impact organism identification leading to incorrect results.Biomérieux local customer service has worked with the customer, confirmed proper use of the vitek pickme tool for spot preparation.Per local customer service, the customer is no longer experiencing spot preparation issues.

• Brand Name: VITEK® MS PRIME
• Common Device Name: VITEK® MS PRIME
• 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13903626
• Report Number: 9615754-2022-00053
• Device Sequence Number: 4391556
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/12/2022

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
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 07/12/2022
• 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