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

A customer in portugal notified biomérieux of obtaining misidentification and low discrimination results in association with the vitek® ms instrument (ref.410895, serial# not provided) using software version v3.2.Initial testing of the patient isolate with the vitek® ms instrument obtained an identification of legionella anisa.The customer repeated testing two (2) days later with an isolate sourced from the same agar plate.Repeat testing identified the isolate as micrococcus luteus.The customer confirmed the isolate was cultured on tsa agar for approximately forty-eight (48) hours at 30-35°c.The customer confirmed the m.Luteus result aligned with the gram-positive cocci stain results.The isolate was sent to charles river laboratories and tested using the 16s dna test method.The 16s dna test method identified the isolate as m.Luteus.For a separate isolate, the customer stated they obtained a low-discrimination result between legionella pneumophila and staphylococcus warneri.The sample was repeated and a result of staphylococcus warneri was obtained.This aligned with the gram-positive cocci stain result.Note: a low discrimination result containing the expected identification is not considered a misidentification or product malfunction.The customer confirmed the isolate was cultured on tsa agar for approximately forty-eight (48) hours at 30-35°c.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

Context: a customer in portugal notified biomérieux of obtaining misidentification and low discrimination results in association with the vitek® ms instrument (ref.410895, serial# not provided) using software version v3.2.Sample: wqb111s vitek ms results : -one single choice to legionella anisa - one single choice to micrococcus luteus other method : - gram coloration test ,the culture looked as a positive coccus which is in favor of micrococcus luteus -16 s dna micrococcus luteus culture conditions : -culture media = tsa -incubation = aerobic conditions at 30-35ºc for approximately 48 hours expected id: micrococcus luteus sample : (b)(4).Vitek ms results : - low discrimination (50%/50%) result legionella pneumophila and staphylococcus warneri - one single choice to staphylococcus warneri other method : - gram coloration test ,the culture looked as a positive coccus which is in favor of staphylococcus warneri culture conditions : -culture media = tsa -incubation = aerobic conditions at 30-35ºc for approximately 24 hours expected id: unknown batch history record and complaint trend analysis there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation: *************** fine tuning according to the vilink alert tool criteria, no fine tuning was needed during the tests performed the 03 and 07 jun 2022.Moreover the fine tuning done previously need to be optimized so a new fine tuning is needed.Spot preparation quality the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.It needs to be verified with the customer and to check if vitek pick me is used and which media is used.Knowledge base review the expected identification for wqb111s is micrococcus luteus which is present in the vitek ms kb v3.2.The expected identification for l5b326s seems to be staphylococcus warneri which is present in the vitek ms kb v3.2.Sample data analysis the sample « all peaks » values are quite heterogeneous, it varies between 35 and 59.Sample spot preparation needs to be verified with the customer.The two potential misidentification were obtained from two spectra having a low number of peaks (34 and 37) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (minimum of 30 for bacteria).In addition, for wqb111s, discrepant result was obtained from spectra having a low identification score (-0,35) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).Moreover a low discrimination is not a final result as mentioned in the user manual 161150-924 ¿ a * additional laboratory tests as determined by microbiology laboratory protocols for low discrimination results are necessary for the completion of the organism identification.* 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: ************** root cause analysis : non optimal 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: celine lacroix gimon ; 5 rue des aqueducs; craponne, MO ; FR
• MDR Report Key: 14919521
• MDR Text Key: 303162808
• Report Number: 9615754-2022-00087
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 08/30/2022

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: 06/27/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1