MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS MYCOB/NOCARDIA KIT

Model Number	410895
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the vitek® ms mycobacterium/nocardia kit provides the reagents and consumables needed to process samples by protein extraction and inactivation for mycobacterium and nocardia identification using the vitek® ms system.The vitek® ms system is a mass spectrometer using maldi-tof (matrix-assisted laser desorption/ionization-time of flight) technology for the identification of microorganisms cultured from clinical specimens.Description of the issue: a customer in (b)(6) notified biomérieux of long drying time using the vitek® ms mycobacterium/nocardia kit - reference 415659 lot #51065.The customer reported long sample drying issue, sometimes >5 hours, affecting both quality control samples and clinical samples.The issue causes acquisition to only be possible the next day; therefore there is delay in results >24 hours.No patient impact has been disclosed by the customer as a consequence of delayed results.Biomérieux global customer service (gcs) recommended the following setup protocol to assist with the drying time: - use a halogen (not led) bulb of 50 watts - turn the lamp on - position the bulb about 18-20 cm from the slides - perform slide deposits as usual (can be performed under the lamp or prior to placing the slides under the lamp) - once spots are dry, leave them between 10 to 15 minutes only, turn the lamp off and proceed with analysis on vitek ms - do not leave the slide more than 45 minutes under the lamp a biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
Customer used vitek® ms mycobacterium/nocardia kit (ref.415659, batch 1008035370) for extraction and inactivation of mycobacterial specimen and quality control strains.In addition, customer is an experienced user in using vitek ms for mycobacteria identification.The workflow in her laboratory was also verified with the biomérieux subsidiary to rule out potential user errors.The mycobacterial atcc® strains they have used in the workflow were well identified in the past : atcc-19977 m.Abscessus, atcc-6841 m.Fortuitum, atcc-19420 m.Smegmatis, atcc-14470 m.Gordonae, atcc-13950 m.Intracellulare, atcc-51985 m.Lentiflavum.Clinical samples of mycobacterium marinum, mycobacterium gordonae and mycobacterium mucogenicum.No patient or operator death, no patient or operator harmed, no indirect patient harm reported, no patient harmed/treated incorrectly.Investigation: the customer obtained ¿no identification¿ results with mycobacteria protocol.Consequently, no trend analysis has been done because vitek ms did not provide erroneous results.In this case, instructions are written in the vitek ms workflow user manual explaining how to manage the ¿no id¿ results.Fine tuning: the fine tuning analyzer report for the last fine tuning done before the identification issue has not been provided.Consequently, it was not possible to conclude on the fine tuning quality before the identification issue.Spot preparation quality: the calibrator ¿all peaks¿ values are heterogeneous.This could be explained by a non-optimal spot preparation of the calibrator strain (culture, spot, different operator¿).This finding has no link with the sample preparation quality during the issue because the customer used the specific vitek ms myco/noc identification protocol.The sample preparation should be homogeneous as the final sample placed on the slide is a liquid.Knowledge base (kb) review: the expected identification were atcc-19977, mycobacterium abscessus; atcc-6841, mycobacterium fortuitum; atcc-19420, mycobacterium smegmatis; atcc-14470, mycobacterium gordonae; atcc-13950, mycobacterium intracellulare; atcc-51985, mycobacterium lentiflavum because these strains were quality control strains used as positive control.Sample data analysis: by reprocessing the customer data with vitek ms kb v3.2, spectra led to: - 1 not enough peaks - 11 x empty spectra - 6 x too noisy spectra - 2 x too many peaks - 8 no identification other results identify the expected species.Reprocessing of the customer data with vitek ms kb v3.2 allows to show that the no identification results were due to ¿empty¿ spectra, ¿too noisy¿ spectra , ¿too many peaks spectra or spectra with ¿not enough peaks¿.The "too noisy or too many peaks" spectra have a high number of peaks.This phenomenon is observed when there is not enough material (organism) on the spot or when the fine tuning is non optimal (laser too high, detector too high).The "empty spectra" have no peak.This phenomenon is observed when no spectra were acquired during the acquisition.For spectra with "not enough peaks", below 30 peaks, the system return bad spectrum information.When the number of peaks is just over 30, the risk to get ¿doubtful¿ results is high due to a lack of information (missing peaks, not enough peaks to eliminate candidate identification).According to this data, the non-optimal spot preparation cause was not retained.The issue seems to be linked to a non-optimal fine tuning.The final root cause could not be established on sample data alone.Root cause: unknown.The customer is being monitored following new fine tuning and tests with specific protocol to improve any sample drying time issue.Corrective actions: the investigator requested that should the issue recur, the customer should provide the fine tuning analyzer report for the last fine tuning done before the identification issue.Without these data, the identification conclusion is difficult to confirm.

• Brand Name: VITEK MS MYCOB/NOCARDIA KIT
• Common Device Name: VITEK MS MYCOB/NOCARDIA KIT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11801027
• Report Number: 9615754-2021-00158
• Device Sequence Number: 14414763
• Product Code: PEX
• UDI-Device Identifier: 03573026436971
• UDI-Public: 03573026436971
• Combination Product (Y/N): N
• PMA/510(K) Number: K162950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 410895
• Device Catalogue Number: 415659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1