MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS INSTRUMENT; VITEK® MS INSTRUMENT

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of obtaining misidentifications during mould negative quality control testing with the vitek® ms instrument (ref.410895, serial number (b)(4)).The customer reported four failed vitek® ms mould runs in which the positive control was conform but the negative control (matrix alone with no microorganism) gave an erroneous identification instead of no identification.The identifications for the negative control given by vitek ms were: low discrimination as mucor circinelloides / microsporum gypseum / sarcladium kiliense.Single choice as saksenaea erythrospora.Single choice as microsporum gypseum.Single choice as trichophyton violaceum.There is no patient associated with this qc testing; therefore, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been completed with the following results: fine tuning: the status was good at the time of acquisition but the level of resolution and s/n were very high which can generate interfering peaks.Monitoring of the fine tuning status with vilink alert tool is useful only if all mandatory fine tuning criteria have been met.In this case, fine tuning was not conform, and it could have had an impact on the vitek ms performances.Vilink alert tool criteria monitoring is only based on the number of ¿all peaks¿ and number of ¿good peaks¿.Spot preparation quality -the customer¿s spot preparation quality was not optimal.The sample ¿all peaks¿ values were quite heterogeneous.However, this root cause will be not retained as a cause of the identification issue because for this case, the customer followed the vitek ms mould protocol.The final sample deposit was liquid and all spots should be homogenous.Sample data analysis -according to data provided, the misidentification results were obtained from the spectra having the lower number of peaks (between 22 and 33) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (20 peaks for fungi).In addition, the misidentification was obtained with a low identification score (between -0.39 and ¿ 0.15) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).For these four (4) negative control spectra, the resolution values were very low (between 3 and 80) in comparison of the four (4) positive control spectra (between 677 and 792).The s/n values were very low (between 0 and 1) in comparison of the 4 positive control spectra (between 39 and 161).According to this data, the quality of negative control spectra was very bad and misid could be explain by the present of interfering peaks.When the small peaks threshold level was increased (at 15mv instead of 0 mv), "no identification" results were obtained and there was no longer a misidentification.These results could be explained by the presence of an important level of interfering peaks and confirm that the fine tuning was not optimal.Root cause analysis: fine tuning did not conform.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10496854
• MDR Text Key: 230511277
• Report Number: 9615754-2020-00145
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

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: Health Professional
• Device Model Number: 410895
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1