MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS INSTRUMENT

Model Number 410895

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a misidentification of a mold isolate as candida orthopilosis in association with the vitek® ms instrument.Reference 410895, serial number (b)(4).Vitek ms gave a result of 93.8 % candida orthopilosis.The culture was grown on sda at 20-25°c for seven (7) days.No patient was involved as this is part of an internal control to optimize identification rate for molds.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following a canadian customer notification of the misidentification of a mold isolate as candida orthopilosis in association with the vitek® ms instrument - reference (b)(4), serial number (b)(6).An internal biomérieux investigation was performed by analyzing the customer¿s provided data.Fine tuning: the vilink® alert tool criteria monitoring is only based on number of ¿all peaks¿ and number of ¿good peaks¿.The previous fine-tuning was not conform.Therefore, the vilink tool cannot be used to determine if fine-tuning was needed at the time of the testing.Spot preparation: sample and calibrator ¿all peaks¿ values are heterogeneous.However, the customer followed the vitek ms mould protocol.The final sample put on the slide is a liquid.Since the customer was using liquid deposit, the spots from the customer must have been homogenous.Organism identification: the expected identification is unknown.The identification has to be confirmed with a reference method (sequencing).According to data provided, the misidentification result was obtained from the spectra having a low number of peaks (31), which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (30).Reprocessing of the customer data with the existing knowledge base (kb) does not reproduce the customer¿s misidentification result.Purpureocillium lilacinum is obtained with vitek ms kb 3.2 and the new kb under development.Purpureocillium lilacinum is a species of filamentous fungus and could be concordant with the macroscopic aspect of the mold strain.The reprocessing of the customer data with the existing kb did not reproduce the misidentification.The investigation found no root cause indicating that there was a malfunction of the system.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10460557
• MDR Text Key: 206162959
• Report Number: 9615754-2020-00139
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• 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: 10/30/2020

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: 07/31/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1