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 result when testing an isolate from an already deceased patient using the vitek® ms instrument (reference 410895, serial (b)(4).The customer reported the vitek ms identified the isolate as clostridium perfringens.Offline test results for this isolate confirmed it was a catalase positive, gram positive diphtheroid that did not grow anaerobically.The clostridium perfringens identification result was not consistent with the offline test results.The customer also tested the isolate using bruker® maldi-tof, which did not identify the isolate.There is no adverse patient impact.The customer confirmed the patient was deceased prior to sample collection and testing.This sample testing was requested by a medical examiner trying to determine cause of death.Biomérieux will initiate in internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in canada regarding a misidentification result when testing an isolate from an already deceased patient using the vitek® ms instrument (reference 410895, serial (b)(4)).The customer reported the vitek ms identified the isolate as clostridium perfringens.Biomérieux internal investigation was conducted.The strain was no longer available for submittal.Evaluation of test data submitted by the customer showed the calibrator "all peaks" values are very heterogeneous.This could be explained by a non-optimal spot preparation of the calibrator strain (culture, spot, different operator).This can be extrapolated to the sample spot preparation.In addition, the fine tuning was non-optimal, one mandatory criteria was not achieved (median of number of peaks was under the minimum value) and the "median of maximum resolution" (593) was below the acceptable value (650).Regarding the complaint description, the expected organism identification is unknown.To confirm the identification, sequencing has to be performed as the reference method.However, the strain is no longer available to perform furthers investigation.The investigation concluded that the probable root causes of the misidentification, based on test data analysis, are: non optimal fine tuning.Non optimal spot preparation.Without submittal of the patient strain, no further investigation is possible.

• 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: 9194851
• MDR Text Key: 196106073
• Report Number: 9615754-2019-00104
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/16/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1