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 Date 10/22/2019

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a failure with the vidas® analyzer ((b)(4)).The customer indicated they obtained a pct result for a (b)(6) month old child that was likely impacted by the issue.Pct result of (b)(6) 2019 was 0.31.Pct result from a second sample tested in a different vidas section on (b)(6) 2019 was >200 ng/ml.It was not possible to re-test the initial sample due to lack of serum.This customer does not perform qcv testing.Qcv testing is required once per week as a functional control.This control is meant to detect residual risks that are rare and sudden.The lack of qcv testing is considered off-label use.At biomérieux's request, the customer performed retrospective analysis for patient samples tested.However, no details of the analysis were provided by the customer; the customer stated only that modified interpretation results were provided to physicians.No feedback from the physicians was provided to the laboratory manager.There is no indication or report from the laboratory that the discrepant pct result led to any adverse event related to the patient's state of health.Biomérieux internal investigation will be conducted.

Manufacturer Narrative

An investigation was completed in response to a customer complaint of a section a1 failure with the vidas® analyzer (ref.410417, s/n (b)(6)).A field service engineer (fse) visited the customer's site on 29oct2019 to determine the cause for the section a1 failure and false result obtained on 24oct2019.The customer did not use section a between 24oct2019 and 29oct2019.This customer does not perform qcv testing.Qcv testing is required once per week as a functional control.This control is meant to detect residual risks that are rare and sudden.The fse performed a qcv on the system.The tv1 expected value is >= 5.3.The actual tv1 value for section a1 was 0.97 (fail) while all other positions passed with tv1 values >= 5.3.The fse performed pump testing on all positions and identified that the pump for position a1 was clogged.The root cause for the false result and qcv failure was determined to be the clogged pump for position a1.The customer's instrument was replaced with a new instrument (s/n (b)(6)).A retrospective analysis was performed from the date of the last preventive maintenance (28aug2019) to the date of the section a1 failure (24oct2019) and only two (2) results were affected.The two (2) affected results have been previously reported in the initial medwatch reports 9615037-2019-00033 and 9615037-2019-00034.There is still no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.

• 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: 9353916
• MDR Text Key: 220579417
• Report Number: 9615037-2019-00034
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1