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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

In response to the customer complaint, biomérieux conducted an internal investigation.Review of the customer¿s data showed the fine-tuning of the vitek® ms instrument was not optimal at the time of the organism misidentification.The review also found the customer¿s spot preparation quality was not optimal; the sample ¿all peaks¿ values were quite heterogeneous.Analysis of the mzml sample show that the misidentification result of brucella spp.Was obtained from the spectra having the lowest number of peaks (30) which is the acceptable limit for giving an ¿identification¿ result rather than a ¿no identification¿ result.This could be caused by the non-optimal spot preparation of the sample strain and by non-optimal fine-tuning.Biomérieux performed a fine-tuning on the customer¿s vitek® ms and provided the customer with spot preparation training materials.

Event Description

A customer in (b)(6) notified biomérieux of misidentification results in association with the vitek®ms instrument (ref.410895, serial number (b)(4)) and knowledge base (kb) version (b)(4) when testing atcc® 43300¿ staphylococcus aureus.The customer cultured atcc® 43300¿ staphylococcus aureus using oxoid columbia blood agar, the culture was then incubated for twenty-four (24) hours prior to testing on the vitek® ms instrument.The customer then tested the atcc® 43300¿ staphylococcus aureus isolate on vitek ms instrument; an identification of brucella sp, was obtained.The isolate was retested eight (8) times.The vitek® ms obtained a single choice to staphylococcus aureus six (6) times and a noid result twice.Additionally, the morphology and biochemical tests performed corresponded to staphylococcus aureus.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.

• 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: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10648855
• MDR Text Key: 241360349
• Report Number: 9615754-2020-00157
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

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: 09/09/2020
• Initial Date FDA Received: 10/08/2020
• 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: N
• Patient Sequence Number: 1