MAUDE Adverse Event Report: BIOMÉRIEUX SA 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
Intended use: 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.Description: a customer in the united states notified biomérieux of obtaining a misidentification of cutibacterium acnes as cutibacterium avidum.In association with the vitek® ms prime (b)(4).The customer reported that the initial testing of the isolate on the vitek ms prime obtained an identification of cutibacterium avidum.While repeat testing with the vitek ms prime and testing on the legacy vitek® ms instrument obtained identifications of cutibacterium acnes.The expected identification was cutibacterium acnes.The isolate was sent to a reference laboratory where it was identified by legacy vitek ms as cutibacterium acnes.Conventional indole testing was positive.This confirmed c.Acnes and ruled out c, avidum.The colony morphology also did not align with an identification of c, avidum.Initial vitek ms prime: cutibacterium avidum.Repeat vitek ms prime: cutibacterium acnes.Legacy vitek ms: cutibacterium acnes.Expected: cutibacterium acnes.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.An investigation has been initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of obtaining a misidentification of cutibacterium acnes as cutibacterium avidum in association with the vitek® ms prime (ref 423281, serial (b)(6)).---investigation--- complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend for the vitek ms prime.Fine tuning: according to the vilink alert tool criteria, no fine tuning was needed on the vitek ms prime during the tests made in december 2022.Based on the calibrator data provided, the instrument seems to be well tuned with good intensity (> 90 mv).Spot preparation quality: the calibrator ¿all peaks¿ values are quite heterogeneous, it varies between 65 to 102.Knowledge base (kb) review: cutibacterium avidum and cutibacterium acnes are present in vitek ms kb v3.2 customer data analysis: regarding the sample spectra which gave the misidentification to cutibacterium avidum (spot e3), there is a low number of peaks and there are hemoglobin peaks in the sample spectra (near 15 kda , near 7.5 kda and near 5 kda).The hemoglobin peaks are prominent and prevent the expression of the other proteins, leading to very few number of peaks and consequently giving the misidentification.In addition, the baseline of the spectra is quite far from the x axis which could be explained by a low biomass on the sample spot e3.The analysis of the sample spectra with mmass software (spot e3) allows to show that three hemoglobin peaks are matching with cutibacterium avidum class (masses at 8036 da, 15047 da and 16070 da).These peaks correspond to three peaks out of the seven specific peaks of cutibacterium avidum class.In addition, only, five peaks are matching with cutibacterium acnes.Based on all these findings, the cause of the misidentification issue is linked to a non-optimal sample spot preparation (presence of hemoglobin peaks and low quantity of peaks detected in the sample spectra).Root cause: the cause for the customer's misidentification has been determined to be due to non-optimal sample spot preparation (presence of hemoglobin peaks and low quantity of peaks detected in the sample spectra).---conclusion--- the investigation determined that there was no malfunction of the vitek ms prime instrument and the cause for the misidentification was user error (specifically non-optimal spot preparation).Local customer service (lcs) has been requested to organize a "spot quality assessment spotting challenge test" with the customer to help improve spot preparation quality.

• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16092281
• Report Number: 9615754-2023-00001
• Device Sequence Number: 15105662
• 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,Followup
• Report Date (Section B): 03/15/2023

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
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/15/2023
• 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