MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK® MS INSTRUMENT

Catalog Number 410895

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification in association with vitek® ms instrument involving a urinary sample.The customer reported the vitek ms did not provide the identification of an organism; however, the organism was identified by vitek 2 as serratia marcescens.The customer reported the results were delayed > 24 hours.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The sample mzml and ecal mzml files were requested from the customer along with the last fine tuning analyzer report.The reports indicated the system has to be checked as the criteria are outside the targets.An investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a misidentification of a serratia marcescens urinary sample in association with vitek® ms instrument (udi (b)(4)), which did not provide the identification.An investigation was performed.The ecal mzml and sample mzml files, and the analyzer fine tuning report were reviewed.The data indicated the fine tuning of the system needed to be checked and the mains fine tuning criteria were outside the targets.Fine tuning was performed and the customer retested the isolate (b)(6) 2016 and vitek ms identified the expected result of serratia marscesens.Further review of the ecal mzml and sample mzml files, showed the number of peaks of ecal spectra varies between 52 and 126 peaks which traduces a spectra variability most likely caused by spot preparation variability.This is also confirmed when we compared spectra from the sample for the initial tests (number of peaks: 136 and 151) and the repeat test (number of peaks: 33).The user performed 2 different spots on the same run and received a no identification result with the error message, "sample spot: too many peaks." in this situation, according to the vitek® ms workflow user manual, the user should "repeat the acquisition for the same deposit.If the message is displayed again, redo the deposit and then the acquisition.If the message recurs, call biomérieux technical assistance or your local biomérieux representative." there is no information on the customer performing other tests with the specimen.The investigation concluded that the system performed as expected, as it provided the no identification with an error message.In this situation, the user has to repeat the deposit, which was eventually done after fine tuning and the expected result (serratia marcescens) was obtained.The first no identification result was most likely caused by a bad deposit that could not be identified by the vitek® ms system.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6154872
• MDR Text Key: 62330771
• Report Number: 3002769706-2016-00499
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410895
• Device Lot Number: 51231
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1