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

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 notified biomérieux of a qcv-detected failure at position e1 in association with their vidas® analyzer (ref.99735, serial (b)(4)).The customer confirmed the qcv-detected failure occurred on (b)(6) 2020, the last successful qcv test occurred on (b)(6) 2020.The customer performed a retrospective analysis for the impacted time frame.The retrospective analysis identified six (6) patient samples were tested in e1 position.Retesting of these samples found one (1) vzv igg) sample initially obtained a false negative result; the five (5) remaining samples showed no interpretation change from the initial test result.The customer confirmed the false negative vzv igg result was reported to the physician; however, there is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux field service engineer (fse) visited the customer site and found the pump at section e1 was clogged.The fse performed a pump cleaner and noted debris from section e1; afterward a qcv test was performed and obtained passing results.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint from the united states regarding a qcv-detected failure at position e1 in association with their vidas® analyzer (ref.(b)(4), serial (b)(6)).A qcv failure is not an abnormal behavior.It means that the qcv played 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.A biomérieux field service engineer (fse) visited the customer site and found the pump at section e1 was clogged.The fse inspected and replaced the seals, performed a pump cleaner and noted debris from section e1.After cleaning and seal change, section e1 passed pump test.The tv1 result values were correct on all positions and qcv test passed.See section h10.

• Brand Name: VIDAS ANALYSER
• Type of Device: VIDAS® ANALYSER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze ; IT
• MDR Report Key: 10033584
• MDR Text Key: 221030193
• Report Number: 9615037-2020-00028
• Device Sequence Number: 1
• Product Code: DEW
• Combination Product (y/n): N
• PMA/PMN Number: K891385
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1