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

Model Number 410417

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 (b)(6) contacted biomérieux to report a qcv-detected failure in section c1 of the vidas® instrument (reference 410417, serial (b)(4)) using qcv lot 200326-0.The qcv-detected failure occurred on (b)(6) 2019; the most recent successful qcv occurred (b)(6) 2019.The customer performed a retrospective analysis for this affected timeframe.Review of the initial and re-test results submitted by the customer determined one false (b)(6) result was obtained but not reported to the treating physician.The customer did confirm there was a one day delay in reporting due to retesting from a new collection and testing in another section.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 internal investigation will be conducted.

Manufacturer Narrative

Biomerieux performed an internal investigation in response to a qcv detected failure at position c1 in which one false positive hiv result was obtained but not reported to the treating physician.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.After the qcv-detected failure occurred at the c1 position, the customer cleaned the spr block and reagent strip tray.The purpose of the spr block cleaning is to remove any dust particles which can clog the pump liner.The customer performed another qcv at the c1 position after cleaning the instrument and obtained passing results.The investigation concluded the qcv failure was likely due to a clog in on the c1 channel liner a field safety notice (fsca 3749-1) was issued 28-mar-2018 advising customers to increase the frequency of the quality control vidas® (qcv®) testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed.

• 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: 8866734
• MDR Text Key: 188863291
• Report Number: 9615037-2019-00013
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/20/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1