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 that they obtained an organism misidentification in association with their vitek® ms instrument (ref: 410895, s/n: unknown): gram staining was cocci, but result of identification was salmonella (gram negative rods).Investigation the investigator reviewed historical complaints and the device history record.Since january 2016, no similar complaint has been recorded.There are also no capas, nor non-conformities on vitek ms linked with customer complaint.Fine tuning status good at the time of acquisition.However, fine tuning performed on (b)(6) 2021 did not meet all of the mandatory criteria.Without meeting all specifications, fine tuning information may not reflect the true state of the instrument.Spot preparation quality the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review the expected identification is unknown because no reference method was used to confirm the expected identification.The customer could confirm the identification by sequencing.Sample data analysis according to data provided, the misidentification result was obtained from the spectra having a low number of peaks (46).Moreover, the misidentification was obtained with a low identification score (-0.36) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).By reprocessing the customer data with saramis kb v4.17 (ruo), spectra which gave the misidentification result with ivd knowledge base led to no identification.This suggests the strain could be a species not included in the vitek® ms knowledge base v3.2 library.The following system limitation is mentioned in the vitek ms v3.2 knowledge base user manual ref.161150-924-a: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.* interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ conclusion the quality of the spectra seems to be not optimal.Complementary investigation is needed to find the cause of the misidentification issue and confirm the organism.However, the customer did not save the isolate so it is unavailable.The root cause of the misidentification remains unknown and further investigation is not possible without access to the customer¿s sample.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.

Event Description

A customer in (b)(6) reported an organism misidentification with vitek® ms (ref: 410895, s/n: unknown): gram staining was cocci, but result of identification was salmonella.Biomérieux confirmed that all preparation steps were correct and the instrument had been calibrated two (2) weeks before.There is no indication or report that the misidentification led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be conducted.

• 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: 12960126
• MDR Text Key: 288116642
• Report Number: 9615754-2021-00292
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 12/08/2021

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: 11/08/2021
• Initial Date FDA Received: 12/08/2021
• 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
• Patient Sequence Number: 1