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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An internal biomerieux investigation was performed.Fine tuning, the calibrator spot quality preparation was non optimal.This is a prerequisite for monitoring the system with vilink alert tool, thus the fine tuning status could not be properly evaluated.In addition, the ¿all peak¿ number obtained during the last fine tuning made before the identification issue is quite high compared to the target (131 peaks for a target at 110).Spot preparation was not optimal.The calibrator ¿all peaks¿ values are very heterogeneous.Additionally, the sample ¿all peaks¿ values are heterogeneous; the value between the first test and re-test is very different (37 and 81).Kb review: the actual strain identification is unknown as no reference method (i.E.Sequencing) was used to confirm the identification.Based on the investigation data, the most probable identification (streptococcus pyogenes) is present in the vitek ms kb v3.2.Sample data analysis, reprocessing of the customer data with vitek ms kb v3.2 allows to give one single choice to streptococcus suis and one single choice to streptococcus pyogenes.The potential misidentification to streptococcus suis has been obtained with a low identification score (-0.31) which is near the acceptable limit (-0.4) for giving an ¿identification¿ result or a ¿no identification¿ result.Moreover, the first test leading to the misidentification has a low number of peaks (37), it was near the limit (30 peaks) for giving an ¿identification¿ result or a ¿no identification¿ result.Expected identification after investigation, based on vitek ms retest result, bruker result, agglutination test result and macroscopic appearance, the most probable identification is streptococcus pyogenes, but this would need to be confirmed using a reference method.Root cause analysis, based on the investigation, the root cause was determined to be non-optimal spot preparation.No corrective or preventative action was recommended at this time as it appears the system is working as designed and intended.Additionally, it was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique.

Event Description

A customer in (b)(6) notified biomérieux of obtaining an organism misidentification of a patient sample while using the vitek® ms instrument (ref.410895, serial number (b)(4).The colony isolated from the sample was identified as steptococcus suis (99.9%) on (b)(6) 2021.Based on microscopic examination, they suspected the strain was actually streptococcus pyogenes.Testing via alternative method (bruker) identified the strain as streptococcus pyogenes.In addition, testing by latex agglutination obtained a positive result, indicating the strain to be streptococci group a.On (b)(6) 2021, the customer repeated the vitek® ms testing on a second colony from the same patient sample and obtained identification of streptococcus pyogenes 99.9 %.There is no indication or report from the customer that the discrepant result led to any adverse event related to the patient's state of health.

• 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: jennifer schmatz ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11375364
• MDR Text Key: 242247090
• Report Number: 9615754-2021-00018
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Model Number: 410895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/24/2021
• 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