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  

Event Description

-- intended use -- vitek® ms is a bacterial and fungal identification system which uses the matrix-assisted laser desorption/ionization (maldi) mass spectrometry method from clinical cultures.-- issue description -- a customer in (b)(6) reported obtaining misidentification of e.Coli while using vitek® ms (ref: 410895, s/n: (b)(4)).Summary: vitek ms gave salmonella enterica repeated vitek ms gave e.Coli the morphology on the plate corresponded with e.Coli no additional test was done and the customer reported e.Coli.An investigation has been initiated by biomérieux.There is no indication or report that the discrepant identification led to any adverse event related to any patient's state of health.

Manufacturer Narrative

A customer in canada reported getting a misidentification of escherichia coli as salmonella enterica, while using their vitek® ms instrument (ref: 410895, s/n:(b)(6)).Investigation: the investigator searched the biomérieux complaints database for similar reports.Since (b)(6) 2016, only one other complaint has been recorded where e.Coli was misidentified as s.Enterica.No capas nor non-conformities can be linked with this customer's complaint.Fine-tuning appeared good at the time of acquisition.The customer's spot preparation quality was not optimal; the calibrator 'all peaks' values were heterogeneous.The expected identification of the sample remains unknown because no reference method was used to confirm the organism.Based on the customer's description and biomérieux quality control laboratories' results, the sample is likely e.Coli which is present in knowledge base v3.2.The misidentification was obtained from the spectra having good level of peaks (86) and a correct score level (-0.06).Biomérieux quality control laboratory analyzed the customer strain and did not reproduce the customer¿s misidentification; they obtained the expected identification to escherichia coli.Conclusion: based on the information above, the root cause of this misidentification is non-optimal sample preparation.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 further assist with sample spot preparation.

• 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: 12971664
• MDR Text Key: 288116956
• Report Number: 9615754-2021-00294
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 03/21/2022

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: 12/09/2021
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/21/2022
• 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