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 Date 10/22/2019

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of a qcv failure in section b1 of the vidas instrument (ref.99735, s/n (b)(4)).The customer stated the last successful qcv was performed on (b)(6) 2019.Retrospective analysis to this date identified six (6) patient tests were processed in section b1.The initial and repeat tests of four (4) patients matched; no change in interpretation.Two (2) patient results (procalcitonin, pct) were potentially impacted by the section b1 issue.- patient 1 (fda medwatch 9615037-2019-00031): the initial result of one sample was <0.05; when repeated in section a the result was 27.Another pct test performed two (2) days later gave a result of 17.This patient was already on vancomycin.- patient 2 (fda medwatch 9615037-2019-00032): the initial result of one sample was 0.09; when repeated in section a the result was 0.7.Both patients are hospital inpatients.The initial results were reported to the physician.The customer stated they have no information regarding any adverse impact to patient.The customer indicated they perform vidas cleaning with tergazyme and 10% bleach diluted with deionized water.The recommended cleaning agents are alconox or liquinox.Biomérieux internal investigation will be conducted.

Manufacturer Narrative

This report was initially submitted following notification by a customer in the united states regarding two (2) false negative and under-estimated vidas® pct results identified during retrospective analysis following two qcv-detected failures in section b1 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 24-oct-2019 to repair and qualify the instrument.The fse performed the following actions: visual inspection of the seals , nothing atypical was noted.Visual inspection in the tray, on the door, on the shield insulate plate, and on the bottom of the frame: no unstruck dots were observed.Replacement of the seals.Performed a pump tester which failed.Performed a pump cleaning on the section b.Performed a new pump tester after the cleaning: all results passed after cleaning.Check spr block and adjust.Check tower height and adjust.Check pump block.Performed a leak test and a qcv test in all positions of the instrument.All results passed.Root cause: pump clog on position b1.Investigation concluded the qcv failure was due to a clog in position 1 of section b.After a cleaning of the position b1, 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: 9353434
• MDR Text Key: 219571374
• Report Number: 9615037-2019-00031
• Device Sequence Number: 1
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1