MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT; VITEK® MS INSTRUMENT

Model Number 410895

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of an organism misidentification using vitek® ms (ref.410895, s/n: (b)(4) in conjunction with knowledge base (kb) version (b)(4).The customer had a green colony cultured on tsab (thermofisher).The strain has been characterized as oxidase positive.The bacterial strain was sourced from a stool sample from an adult male, (b)(6), hospitalized for diarrhea.The green colony was analyzed on vitek® ms instrument.The result was vibrio alginolyticus with 99.9% confidence.This identification was reported to physician.The green colony was then subcultured on tcsb at 35°c overnight.Small colonies became visible, still oxidase positive.Xld medium was also inoculated for two (2) days from the original sample.Colonies from tsab, tcsb and xld media were tested on vitek® ms.The result was vibrio parahemolyticus with 99.9% confidence.In parallel, a vitek® 2 gn id card was tested with colonies from the tsab medium.The result was vibrio parahemolyticus at 99.9% confidence.In summary: initial vitek® ms testing: vibrio alginolyticus.Repeat vitek® ms testing with colonies from three (3) different plate media: vibrio parahemolyticus.Alternate method, vitek® 2 gn id card: vibrio parahemolyticus.There is no reported harm to the patient.

Manufacturer Narrative

A customer in singapore notified biomérieux of obtaining a misidentification of vibrio parahaemolyticus as vibrio alginolyicus in association with their vitek® ms instrument (ref.(b)(4); serial# (b)(6)).The first test ((b)(6) 2021) gave a single choice result of v.Alginolyticus.The second test ((b)(6) 2021) gave three (3) results of v.Parahaemolyticus.Oxidase testing and results using vitek 2 gn id card also suggested an identification of v.Parahaemolyticus.Investigation: fine tuning: according to vilink alert tool criteria, no fine-tuning was needed during the tests made on (b)(6) 2021.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous (between 75 and 121).Optimal preparation should yield homogeneous values.Further, the v.Alginolyticus result was obtained with a low identification score (-0.30) which is near the acceptable limit for giving an identification result or a ¿no identification¿ result (-0.4).Knowledge base (kb) review: the expected identification remains unknown as it was not confirmed using a reference method.Based on oxidase and vitek 2 tests, the most probable identification is v.Parahaemolyticus which is present in the customer¿s knowledge base version (v3.2).Sample data analysis: the spectra leading to the v.Alginolyticus result displays a mass shift.The mass shift was not the same over all the spectra, suggesting non-optimal spot preparation quality.For this result, the maximum resolution at 348 was non-optimal.With sub-optimal resolution, the algorithm has difficulties defining the exact position of the peaks (masses) and they may appear shifted.The three (3) sets of spectra leading to the v.Parahaemolyticus result, had maximum resolutions between 750 and 800 (correct value).Analysis of calibrator spectra linked to the samples show the peak intensities acquired during the first reading of the calibrator spot were very low compared to the second reading, also suggesting non-optimal calibrator spot preparation.Root cause: based on the findings above, root cause was determined to be non-optimal spot preparation.It was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique.

• 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
• MDR Report Key: 11233010
• MDR Text Key: 240970751
• Report Number: 9615754-2021-00013
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR