MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS INSTRUMENT

Catalog Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer reported to biomerieux a misidentification event occurred when using the vitek ms instrument.The customer reported that the vitek ms instrument returned a result of vibrio mimicus; however, the vitek 2 instrument returned a result of vibrio cholera.When specifically asked, the customer indicated no adverse impact to the patient or delay in results was experienced as a result of this event.An investigation has been initiated by biomerieux to investigate this event.

Manufacturer Narrative

A customer notified biomérieux of a misidentification of vibrio cholerae as vibrio mimicus in association with the vitek ms instrument.Customer testing: suspected misidentification with vitek ms in ivd mode: -vitek 2 result : vibrio cholerae 93% - vitek ms result : vibrio mimicus 99.9% - sequencing : vibrio cholerae - vitek 2: vibrio cholerae isolate type: blood culture bottle.Culture conditions: culture pure.The culture media for testing was tsab (asan pharma) and it is incubated at 37°c for 18 hrs in the ambient air.The customer repeated the test to comply with the user manual (the first misidentification was obtained after four (4) shots on the same spot which is not a correct use of the system).After retest the same identification result (vibrio mimicus) was obtained.The customer provided additional information regarding the patient's outcome.After collecting the blood culture bottles, and prior to any diagnostic testing, the patient expired.The patient death was not a result of the discrepant vitek® ms organism identification.Specimen testing occurred after patient death.An internal biomérieux investigation was performed.Investigational testing: vitek ms customer's spectra have been analyzed and are more aligned with vibrio mimicus reference spectra than vibrio cholerae.Based on in-depth analysis of nucleic acid sequence of this strain by r&d, the vitek ms misidentification is not confirmed.Results are nearly equal for vibrio cholerae and vibrio mimicus.Typically, discrimination between vibrio cholerae and vibrio mimicus is possible with full 16s gene sequencing.The customer sequenced 1476 base-pairs (16s full).However, for this specific strain, it is not possible to determine if it is a vibrio cholerae or a vibrio mimicus.Moreover, r&d analyzed vitek 2 results obtained by the customer and biochemical tests indicate that the isolate is atypical.In conclusion, a vitek ms malfunction cannot be confirmed.Based on sequencing results, it is not possible to determine if the strain is a vibrio mimicus or a vibrio cholerae.Consequently, there is no evidence that vitek ms provided an incorrect identification result.This is the first complaint recorded regarding identification issue for vibrio cholerae.The investigation concluded there is no evidence the vitek® ms is performing outside of specifications.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5979918
• MDR Text Key: 55712183
• Report Number: 3002769706-2016-00347
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/28/2016

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: 410895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1