MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® EASYMAG® DISPOSABLE

Catalog Number 280135

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report intermittent lls errors in association with the nuclisens® easymag® disposable vessels used on one of their easymag® systems.The customer reported that results were delayed more than 24 hours with no impact to patient care.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer in martinique who contacted biomérieux to report intermittent lls errors in association with the nuclisens® easymag® disposable vessels used on their easymag® systems.The customer reported obtaining several random lls errors on his two easymags with several vessel batches (z108kb / z109am / z109do and z109fn).The customer also reported solving the lls errors by switching on another disposable batch z109km.The customer sent the data for the impacted samples ( plasma, respiratory samples (throat swab, sputum), urine) which were pre-treated when necessary.The fse (field service engineer) visited the site and found no equipment issue via the lls test performed and no particular issue highlighted.The run report was analyzed by r&d and service engineering : lls errors are due to tips clogged by samples (not homogenous) and were displayed on different positions on the vessel, since lls occurred at the first aspiration, it seems to be sample related or due to crystals in the lysis buffer (occurring when the buffer is stored below the ambient temperature) the impacted samples failed as no eluate obtained.The storage conditions of the lysis buffer 1l are not clear and could be the root cause.Disposables supplier medisize was informed on (b)(6) 2018 : complaint (b)(4) opened on (b)(6) 2018.Batch documentation showed no direct link between the impacted batches.Z108kb and z109am were manufactured with old plastic raw material (moplen) whereas z109do and z109fn are made of new raw material (sabic) review of batch documentation for both assembled product and injection moulding products showed no non conformity / planned deviation / complaint related to these batches.The exact root cause is unknown, however, the most probable cause is that tips were clogged by lysis buffer crystals causing lls errors on the easymag instruments.

• Brand Name: NUCLISENS® EASYMAG® DISPOSABLE
• Type of Device: NUCLISENS® EASYMAG® DISPOSABLE
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des berges; grenoble cedex, 38024 ; FR 38024
• MDR Report Key: 7802499
• MDR Text Key: 118398440
• Report Number: 3002769706-2018-00155
• Device Sequence Number: 1
• Product Code: JJH
• UDI-Device Identifier: 03573026139360
• UDI-Public: 03573026139360
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: 280135
• Device Lot Number: Z109FN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1