MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT

Model Number 410895

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

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

Event Type  malfunction  

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of obtaining a misidentification of escherichia coli as mycobacterium flavescens in association with the vitek® ms (ref 410895, serial (b)(4).Investigation: complaint and device history record review: the complaint investigator checked the complaints database to search for similar reports.Since january 2016, no other complaint has been recorded for an escherichia coli misidentified as microbacterium flavescens/laevaniformans.Review of the device history record did not document any issues during manufacturing or packaging.No capas nor non-conformities can be linked to the customer¿s complaint.Fine tuning: according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 2021.However, for the tests before that, fine tuning did not meet all of the necessary criteria.Spot preparation quality: the calibrator ¿all peaks¿ values were heterogeneous, indicating that spot preparation was not optimal.Knowledge base review: customer states the expected identification is escherichia coli which is present in the vitek ms kb v3.2.However, they did not specify the method of identification, thus it cannot be confirmed.Sample data analysis: reprocessing the customer data with vitek ms kb v3.2 shows the identification of microbacterium flavescens/laevaniformans was obtained with a low score (-0.24).This is near the limit value of -0.4 for giving a no identification result.Conclusion: per the investigation, root cause of the customer¿s issue is non-optimal spot preparation along with fine tuning that did not meet all of the necessary criteria.Local customer service provided the customer with additional training materials to help improve their spot preparation technique.Customer service also provided information regarding vitek® pickme¿ (ref 423551/ 423546) to help with sample spot preparation.

Event Description

A customer in (b)(6) notified biomérieux of obtaining a misidentification of escherichia coli as mycobacterium flavescens in association with the vitek® ms (ref 410895, serial (b)(4).The escherichia coli strain is associated with vaccine production and the expected identification was provided to the customer by the customer's client.There is no indication or report from the customer that this event led to any adverse event related to any 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13019685
• MDR Text Key: 282491385
• Report Number: 9615754-2021-00296
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 12/16/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/16/2021
• 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: A
• Patient Sequence Number: 1