MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS PLUS

Catalog Number 4702842

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not received from customer.

Event Description

A customer in (b)(6) reported inconsistent organism identification of candida albicans as candida pulcherrima (2 of 4 test slide spots) in association with the vitek ms plus version 2.0 identification system.Confirmatory testing was also performed by the customer via chromid agar and vitek 2.Both methods provided results of candida albicans.Candida albicans was reported to the physician.Analysis of the data included in the mzml log and ecal files provided by the customer was performed by biomerieux.Version 2 knowledge base (kb) - same results as the customer (spots 1, 2 = c.Pulcherima and 3, 4 = c.Albicans).Version 2.1 kb - spots 1, 2 = no identification and 3, 4 = c.Albicans.Version 3.1 kb - spots 1, 2 = no identification and 3, 4 = c.Albicans.The knowledge base analysis and mass analysis of the files strongly suggest the issue is due to poor spot preparation by the user.This is based on the lower number of peaks present on the misidentified spots as compared to the isolates that identified correctly.In addition, there is a higher intensity of the peaks and higher masses present in the correctly identified isolates as opposed to the misidentifications.The level 2 investigation concluded the spotting technique used by the customer is inconsistent.There is no indication or report from the hospital or treating physician to biomerieux that the occurrence led to any adverse event related to the patient's state of health.There may be a potential for adverse event if only one spot is prepared or if all spots provide the same incorrect organism identification however unlikely.Though the vitek ms plus is not marketed/sold in the united states, a similar device (vitek ms) is.An internal biomerieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted due to vitek® ms misidentification of candida albicans as candida pulcherima.Biomérieux investigation was conducted via review of the ecal and mzml log files submitted from the customer site.Eight ecal mzml files.Five sample mzml files.Last fine-tuning: end of june 2016.< ecal spots analysis > only eight (8) ecal mzml files were received.This represents only four (4) calibration spots that were shot twice.This is not enough data to determine if fine-tuning is needed.< sample spot analysis > two (2) sample mzml files were received that gave misidentifications as candida pulcherima.Three (3) other sample mzml files were received that gave correct identifications to use as comparisons.All five (5) samples were analyzed with the cli 2.0 fungal knowledge base (kb), the cli 2.1 fungal kb, and the ind 3.1 fungal kb.Due to the low number of ecal files received, it cannot be determined whether fine-tuning was a cause in the misidentification of the organism.However, based on the knowledge base analysis and mass analysis of the files, the issue may be due more to spot preparation.This is seen from the lower number of peaks present on the misidentifications as compared to the isolates that identified correctly.This also appears to be indicated by the higher intensity of the peaks and the higher masses present in the identified isolates as opposed to the misidentifications.The investigation concluded the vitek® ms is performing as intended.The misidentification was the result of user test setup.

• Brand Name: VITEK® MS PLUS
• Type of Device: VITEK® MS PLUS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5883773
• MDR Text Key: 52722996
• Report Number: 3002769706-2016-00141
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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 Catalogue Number: 4702842
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• 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