MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS INSTRUMENT - 410895

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  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a misidentification result when testing a strain from a proficiency test with vitek® ms instrument (reference 410895, serial number (b)(4)).The expected result was corynebacterium ulcerans; however, the customer obtained three (3) different types of result: no id, coryne pseudotuberculosis / coryne ulcerans with low discrimination, nocardia transvalensis 99.9 %.The customer confirmed that this event did not impact any patient's state of health, nor did it lead to a delay in reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a misidentification result when testing a strain from a proficiency test with vitek® ms instrument (reference 410895, serial number (b)(6)).The customer's raw data was analyzed.The fine tuning performed prior to testing met all mandatory acceptance criteria and the raw data indicated that a new fine tuning was not needed during the customer's testing.The instrument was fully operational during the customer's testing.The customer's spot preparation was evaluated and found to be non-optimal.The calibrator and sample ¿all peaks¿ values are quite heterogeneous.These data also show that the misidentification result as nocardia transvalensis was obtained with a low score value (-0.32) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).In addition, for the low discrimination result as c.Ulcerans ¿ c.Pseudotuberculosis, c.Pseudotuberculosis identification had a low score value (-0.39) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).Local customer service (lcs) has been instructed to provide the customer with additional training materials to improve spot preparation technique.See h10 for addtl mfg narrative.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 9850035
• MDR Text Key: 206149074
• Report Number: 9615754-2020-00041
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1