MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER

Model Number 99735

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in the united states contacted biomérieux to report a qcv-detected failure in section a1 of the vidas® analyzer (reference 99735, serial (b)(4)).The qcv detected failure occurred on (b)(6) 2019 the most recent successful qcv occurred on (b)(6) 2019.A retrospective analysis was performed for the affected timeframe.The customer had performed 12 pct (procalcitonin) assays at position a1 since the last successful qcv on (b)(6) 2019.Eleven (11) of the pct samples were retested.One sample was not able to be rerun; therefore, a new sample specimen for this patient was tested.Review of the initial and re-test results submitted by the customer determined nine (9) pct samples had no interpretation change, and three (3) were falsely underestimated.A biomérieux field service engineer (fse) visited the customer and confirmed the pump at position a1 was clogged.The fse cleaned the instrument and obtained a passing qcv result.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be conducted.

Manufacturer Narrative

This report was initially submitted following notification by a customer in the united states regarding three (3) falsely under-estimated vidas® pct results identified during retrospective analysis following two qcv-detected failures in section a1 of the vidas® analyzer.It should be noted that a qcv failure is not an abnormal behavior.It indicates that the qcv test performed its role as a functional control.This control is meant to detect residual risks, that are rare and sudden.Those risks are already present and accepted into the vidas system risk analysis.The local field service engineer (fse) visited the customer site on 23-sep-2019 to repair and qualify the instrument.The fse cleaned section a1 and then performed a leak and qcv test.Both tests obtained passing results.The investigation concluded the qcv detected failure was caused by a clog in position 1 of section a.After a cleaning of the position a1, the system was qualified.The system is now operating per manufacturing specifications.

• Brand Name: VIDAS® ANALYZER
• Type of Device: VIDAS® ANALYZER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; 50012 bagno a ripoli; firenze, ; IT
• MDR Report Key: 9221199
• MDR Text Key: 217336398
• Report Number: 9615037-2019-00026
• Device Sequence Number: 1
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (y/n): N
• PMA/PMN Number: K923579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1