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  

Event Description

A customer in the united states contacted biomérieux to report a qcv-detected failure of the vidas® analyzer (reference (b)(4), serial (b)(4)).The qcv detected failure occurred on (b)(6) 2019 the most recent successful qcv occurred on (b)(6) 2019.The customer performed a retrospective analysis following a qcv detected failure on position a1 for the affected timeframe.The customer stated a total of forty-seven (47) patients samples were tested at position a1 during the affected timeframe, six (6) patients samples were found to be underestimated for procalcitonin (pct).Results for sample c are listed below: sample c: pct reported value = 0.15 ng/ml ; pct repeat value = 21.06 ng/mll.The customer reported that these results (original and corrected results) have been reported to the physician.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 and confirmed the pump at position a1 was clogged.The fse cleaned the pump and replaced the seals.The fse then performed a qcv and leak test, all results passed.A biomérieux internal investigation will be conducted.

Manufacturer Narrative

An internal investigation was initiated following the notification of six falsely underestimated vidas® procalcitonin (pct) results identified following a qcv-detected failure in section a1 of the vidas® analyzer.It should be noted 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.The local field service engineer (fse) visited the customer site on 30-nov-2019 to repair and qualify the instrument.The fse performed the following actions: visual inspection of the seals.Replacement of the seals.Visual inspection in the tray, on the door, on the shield insulate plate, and on the bottom of the frame.Performed a pump tester, which failed in section a1.Performed a pump cleaning on the section a.Performed a new pump tester after the cleaning: all results passed.Door plunger ball check.Stricker plate check.Spring integrity check.Free and smooth vertical movement of spr blocks.Cleaned and lubricated the screws holding the spr block.Checked spr block and adjusted.Checked tower height and adjusted.Checked pump block and adjusted.Checked retainer plate integrity.Checked try depth and adjusted.Performed a leak test and a qcv test to qualify the instrument.All results passed.Root cause: pump clog on position a1.The cause of the qcv failure was a clog in position a1.The problem was solved after cleaning the pump and the changing the seals.The system is now operating per manufacturing specifications.Corrected date note: the initial report was submitted with a contact date of 01-dec-2019.Further review of this event confirmed the event did not meet pre criteria until 10-dec-2019.

• 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; firenze 50012 ; IT 50012
• MDR Report Key: 9582283
• MDR Text Key: 220792885
• Report Number: 9615037-2020-00004
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1