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

Model Number 99735

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

On (b)(6) 2020, a customer in the united states notified biomérieux of a qcv detected failure which occurred at section a1 of their vidas® analyser (ref.99735, serial (b)(4)).The customer confirmed the most recent passing qcv test occurred on (b)(6) 2020 and performed a retrospective analysis for the impacted timeframe.The retrospective analysis identified one (1) procalcitonin (pct) sample was initially underestimated.The original test result obtained was <0.05 ng/ml, the repeat test obtained a value of > 2 ng/ml.The customer stated the underestimated result was reported to the physician, and treatment was withheld based upon the underestimated result of <0.05 ng/ml.Treatment of the patient was adjusted after obtaining the corrected value of > 2 ng/ml.Although there is no indication or report from the laboratory that the discrepant result led to any direct negative impact to the patient's state of health, the customer confirmed treatment of the patient was delayed based upon the erroneous underestimated pct result.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a qcv detected failure which occurred at section a1 of their vidas® analyser (ref.99735, serial (b)(6)).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.A field service engineer (fse) visited the customer site and investigated the issue.The cause for the qcv failure on section a1 was identified to be a clog in position a1.According to the biomérieux internal procedures, the fse performed several actions: pump test, then pump cleaning on the positions needed (position a1).After cleaning the positon a1 pump channel, the pump test passed.Leak test and qcv test performed in order to qualify the instrument.The tv1 results and r3 results were correct on all positions, after cleaning pump channel a1.The final qcv test passed and the customer's instrument was qualified for use.

• Brand Name: VIDAS ANALYSER
• Type of Device: VIDAS® ANALYSER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• MDR Report Key: 10105030
• MDR Text Key: 194681391
• Report Number: 9615037-2020-00031
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1