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 a gram-positive organism as escherichia coli while testing an environmental monitoring sample with the vitek® ms (ref 410895, serial (b)(4)).The customer noted that the identification as e.Coli was questionable because the strain did not grow on hektoen agar which is a selective culture medium for gram negative isolation (e.Coli is expected to grow on hektoen agar).The actual identification remains unknown however, as it was not confirmed with any reference method (i.E.Sequencing).There were no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Investigation: the investigator reviewed the complaints database in search of any similar issues which had been previously reported.Since january 2016, no other similar complaint has been recorded for a corynebacterium coyleae misidentified as escherichia coli.No capas nor non-conformities on vitek® ms can be linked with 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, the fine tuning made prior to these tests did not meet all of the necessary criteria (one was not met).A new fine tuning occurred on (b)(6) 2021 and it all criteria were met.Spot preparation: the calibrator ¿all peaks¿ values were heterogeneous; indicating that the spot preparation was not optimal.Knowledge base (kb) review: the actual expected identification remains unknown as no reference method was used to confirm the id.However, the customer believes the organism to be corynebacterium coyleae which is present in the vitek ms kb v3.2.Sample data analysis: the fine tuning made prior to the potential misidentification did not meet all necessary criteria.The test completed following a new fine tuning (where necessary criteria were met) identified the sample as c.Coyleae.This identification is in accordance with the culture obtained on hektoen agar (no growth as it is a gram positive species).However, the identification should be confirmed with the reference method (sequencing).The spot k2 which gave the potential misidentification to escherichia coli is near the calibrator spot.The analysis of the spectra from spot k2 show that a lot of specific peaks for e.Coli are present in the spectra.This suggests a potential mix between the sample spot and the calibrator spot.In addition, the calibrator spot preparation was non optimal.Conclusion the investigator concluded that the customer issue occurred due to non-optimal spot preparation in conjunction with fine tuning that did not meet all necessary criteria.Local customer service provided additional training materials to the customer to help improve the spot preparation technique and discussed the importance of following the correct protocol (bacteria vs yeast) to obtain correct identifications.Customer service also provided information regarding vitek® pickme¿ (ref 423551/ 423546) to further assist with sample spot preparation.

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.Description: a customer in (b)(6) notified biomérieux of obtaining a misidentification of a gram-positive organism as escherichia coli while testing an environmental monitoring sample with the vitek® ms (ref 410895, serial (b)(4)).The initial identification obtained by the vitek ms was escherichia coli.Escherichia coli is a gram-negative organism.The customer had also performed gram staining and used selective media that selects against gram-positive organisms.The organism was determined to be gram-positive and did not grow on the selective media.Gram stain: gram-positive bacilli.Hektoen media (inhibition of gram-positive): no growth.Initial vitek ms: escherichia coli.Repeat vitek ms: corynebacterium coyleae.As this was an environmental monitoring sample, there is no patient involved.Biomérieux conducted an internal investigation.

• 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: 13101659
• MDR Text Key: 290782397
• Report Number: 9615754-2021-00300
• 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: 12/28/2021

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: 11/29/2021
• Initial Date FDA Received: 12/28/2021
• 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