MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYSER - 99735

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  

Manufacturer Narrative

Device was not returned to the manufacturer.

Event Description

A customer in the united states notified biomérieux of a qcv detected failure in association with the vidas analyser (ref 99735, serial (b)(4)).The customer indicated that the instrument failed in section d position 1 with a tv1 value lower than expected.The customer performed a retrospective analysis on all samples tested in position d1 from 17-nov-2019 (date of last correct qcv result) to 25-nov-2019 (date of qcv failure).Of 34 samples run in that time frame, the customer was able to retest 16 samples and identified that four (4) samples were impacted by the qcv detected failure.Four vidas pct results were discrepant upon retesting.Of the four samples, only one sample (sample 5) had a vidas pct interpretation change following the retrospective analysis.The initial results for all four samples were reported to the treating physician.After the retrospective analysis, the corrected results were reported to the physician.There is no indication or report from the laboratory that the initial incorrect results led to any adverse event related to any patient's state of health.A field service engineer visited the customer site and cleaned the section d pump.The instrument then performed as intended.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a qcv detected failure in association with the vidas analyser (ref 99735, serial (b)(6)) it should be noted that 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 analyser system risk analysis.A field service engineer (fse) investigated the issue at the customer site and performed the following actions: replacement of the seals.Visual inspection of the seals (unstuck dot, crystallization, misplaced or glued dots, debris, fibres, aluminium particles).Visual inspection (in the tray, on the door, on the shield insulate plate, on the bottom of the frame).Pump tester (expected value = 140).D1 value 55.Section d slot 1 failed pump test.Pump cleaning on the sections where ptv < 140.Conclusion: position d1 was clogged.Leak test and qcv test performed in order to qualify the instrument.On section d1 the new tv1 was inside the ranges, tv1= 7.53.The leak test passed.The system was qualified.Root cause: pump clog on position d1 the investigation concluded that the qcv failure was due to a pump clog in position d1.After a cleaning of the position d1, the system was qualified for use.

• Brand Name: VIDAS® ANALYSER - 99735
• Type of Device: VIDAS® ANALYSER - 99735
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; 50012 bagno a ripoli; firenze ; IT
• MDR Report Key: 9513160
• MDR Text Key: 219570088
• Report Number: 9615037-2019-00044
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1