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 escherichia coli as rahnella aquatilis when testing a patient isolate with the vitek® ms (ref 410895, serial (b)(4)).Repeat testing with the vitek® ms obtained an identification of e.Coli (99.9%).The customer confirmed that e.Coli was the identification reported to the physician.There is no indication or report from the laboratory that the initial discrepant identification led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was completed in response to a customer complaint of a misidentification of escherichia coli as rahnella aquatilis when testing a patient isolate with the vitek® ms (ref: (b)(4), serial: (b)(6).Repeat testing with the vitek® ms obtained an identification of e.Coli (99.9%).Analysis of the customer's raw data identified that the customer's system was operational during testing, but that the spot preparation was non-optimal.The calibrator "all peaks" values were heterogenous.The expected identification of the strain is unknown as no referenced methods were used for identification verification.Based on the data provided by the customer the probable identification is escherichia coli.The suspected cause for the misidentification is non-optimal spot preparation technique.Local customer service (lcs) has been instructed to supply the customer with additional training materials to help improve spot preparation technique.Since january 2016, there have been no other complaints related to misidentifications of escherichia coli as rahnella aquatilis.

• 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: 8857521
• MDR Text Key: 217722118
• Report Number: 9615754-2019-00053
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• 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: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1