MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT; VITEK MS INSTRUMENT - 410895

Model Number 410895

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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: an industry customer in germany reported to biomérieux potential misidentifications for five samples in association with the product vitek ms instrument ref.(b)(4), serial number (b)(4).It was reported that the customer obtained discrepant results with five samples and it is understood that potential vitek ms misidentifications are suspected by the customer, the results were as follows: sample 1:initial test result = actinomyces graevenitzii, rejected because gram-positive cocci in gram.- repeat test result = micrococcus luteus.Sample 2: - initial test result = staphylococcus epidermidis (confidence only 91.8%), rejected because gram positive rods coryne in gram.- repeat test result = unknown.Sample 3: - initial test result = citrobacter freundii (confidence only 97.9%), rejected because gram positive rods in gram.- repeat test result = corynebacterium aurimucosum.Sample 4: initial test result = bacteroides ovatus/xylanisolvens, rejected because gram positive rods coryne in gram.Repeat test result = unknown.Sample 5: initial test result = citrobacter koseri / klebsiella oxytoca (49.4% / 50.6%), rejected since whole order escherichia coli as result.Repeat test result = escherichia coli.There is a suspicion of a non-optimal spot preparation.The presence of hemoglobin peaks is suspected in customer¿s spectra.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 or no identification.A non-optimal sample preparation quality is suspected, probably linked to agar picking during the collection of the colonies on the plate with the pickme pen.Misidentifications related to non-optimal samples preparation have not been confirmed, it has to be verified with the customer and confirmed with the investigation.There is no indication or report from the customer that this event led to any adverse event related to the user/patient's state of health.An investigation has been initiated.

Manufacturer Narrative

Context: ********** an industry customer in germany reported to biomérieux potential misidentifications for five samples in association with the product vitek ms instrument (ref.410895, serial number (b)(6)).Vitek ms mode : ivd kb version : 3.2 (ind) issue type : discrepant results vitek ms result: lab id 2171765: 23 nov 2022: single choice as actinomyces graevenitzii 24 nov 2022: single choice as micrococcus luteus other method: gram-positive cocci in gram (discrepant with actinomyces graevenitzii) lab id 2170509: 22 nov 2022: single choice as staphylococcus epidermidis * other method: gram positive rods coryne form in gram (discrepant with staphylococcus epidermidis) *: reprocessing of data led to noidentification lab id 2168557: 18 nov 2022: single choice as citrobacter freundii 21 nov 2022: single choice as corynebacterium aurimucosum other method:: gram positive rods in gram (discrepant with citrobacter freundii) lab id 2164136: 18 nov 2022: single choice as bacteroides ovatus/xylanisolvens 18 nov 2022: no identification other method: gram positive rods coryne form in gram (discrepant with bacteroides species) lab id 2166247: 16 nov 2022: low discrimination as citrobacter koseri / klebsiella oxytoca 17 nov 2022: single choice as escherichia coli other method: expected as e.Coli expected id: unknown as no identification reference method was performed culture conditions: - spotting tool: pickme pen - origin: unknown - culture media : columbia - incubation: 24 h incubated at 30-35 °c issue date: between 16 nov 2022 to 24 nov 2022 fine tuning date before the issue: 08 nov 2022 and 22 nov 2022 investigation: **************** ** batch history record and complaint trend analysis** there is no capa, no non-conformity on vitek ms linked with customer 's complaint.A trend analysis has been done regarding the complaints recorded for a misidentification; no trend has been identified.**investigation results** *fine tuning status good at the time of acquisition for the both instruments.*spot preparation quality the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous during the issue.*knowledge base (kb) review the expected identifications are unknown because no reference method was used to confirm the expected identifications.*sample data analysis for lab id 2171765, the misidentification as actinomyces graevenitzii was obtained with the lower number of peaks (32).Moreover, the suspected misidentification was obtained with a low identification score (-0.3) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).For lab id 2170509, the misidentification as staphylococcus epidermidis was not observed with the data provided, spectra led to no identification result.For lab id 2168557, the misidentification as citrobacter freundii was obtained with the lower number of peaks (43).Moreover, the suspected misidentification was obtained with a low identification score (-0.2) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).For lab id 2164136, the low discrimination as bacteroides ovatus/xylanisolvens was obtained with the lower number of peaks (39).Moreover, the suspected misidentification was obtained with a low identification score (-0.32) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).For lab id 2166247, the low discrimination as citrobacter koseri / klebsiella oxytoca was obtained with the lower number of peaks (43).Moreover, the suspected misidentification was obtained with a low identification score (-0.03 and -0.26) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿).It needs to be verified with the customer.A system issue should not be considered as the misidentification issues were observed independently with both instruments ((b)(6)).For most of the customer sample spectra, there are presence of peaks near 7.5 kda and near 15 kda (double-charged peak).Based on this observation, we suspect the presence of hemoglobin peaks in these spectra.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 or no identification.Based on these findings (low number of peaks and presence of hemoglobin peaks), a non-optimal sample preparation quality is suspected, probably linked to agar picking during the collection of the colonies from the plate (it could happen for strain with rough colony or for strain difficult to collect).It needs to be verified with the customer.The non-optimal spot preparation of the sample strain could be linked to the spotting with vitek pickme pen.If a spot is too thin, not enough organism have been deposited on the spots.Consequently, the amount of ¿interfering peaks¿ detected during acquisition increase and impact the level of good peaks.It is important not to flip the pen during the deposit as opposed to the loop in order to have enough material on the spot.Meeting was done with the customer 22 nov 2022.It has been mentioned that customer performed matrix aliquot.Matrix aliquot is not a validated process.This can lead to a high risk of degradation of the quality of the matrix (plastic release, loss of stability).Conclusion: ************** the most probable root causes of this issue are: non optimal spot preparation, operator error.According to data above, there is no reconsideration of vitek ms (ref.410895) performance.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT - 410895
• 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: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15931311
• MDR Text Key: 306108472
• Report Number: 9615754-2022-00144
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Device Operator: Other
• Device Model Number: 410895
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1