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

Model 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 in (b)(6) notified biomérieux of a misidentification of clavispora opuntiae as candida famata when testing a patient isolate with the vitek® ms (ref 410895, serial (b)(4).The isolate was collected from a surgical wound.Candida famata was reported to the physician, but did not influence patient treatment or state of health.The customer sent the strain to another lab for antifungal susceptibility testing.The second lab tried to identify the isolate using maldi-tof (bruker), but obtained no identification.26s rrna gene sequencing was then performed and obtained an identification of clavispora opuntiae.Clavispora opuntiae is not a claimed species in the viitek® ms knowledge base (kb).Testing of unclaimed species may result in an unidentified result or a misidentification.While returning an unidentified result for an unclaimed species is not considered a malfunction, assigning the incorrect identity to an unclaimed species is considered to be a malfunction.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in switzerland regarding a misidentification of clavispora opuntiae as candida famata when testing a patient isolate with the vitek® ms (b)(4).The isolate was collected from a surgical wound.Clavispora opuntiae is not a claimed species in the vitek® ms knowledge base (kb).Testing of unclaimed species may result in an unidentified result or a misidentification.An internal biomerieux investigation was performed.Conclusion on the system: the customer's system was within conformance during the test (29 jul 2019).Conclusion on spot preparation quality: the customer's spot preparation quality was good.Conclusion on the identification: regarding the complaint description, the identification is clavispora opuntiae.This is a specie out of our current knowledge bases.The tested species is not included in the vitek® ms knowledge base v3.0 neither vitek® ms kb 3.2.The following system limitation is mentioned in the vitek® ms knowledge base user manual ref.(b)(4) for vitek® ms clinical use v3.0: testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek® ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek® ms results.Vitek® ms r&d has been contacted and has opened a change request to consider adding this species in a future knowledge base.Suspected cause of the issue: system limitation (specie out of the knowledge base v3.0 and v3.2).

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9152991
• MDR Text Key: 219786142
• Report Number: 9615754-2019-00095
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• 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: 12/30/2019

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: 09/08/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1