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

Catalog Number	280135
Medical Device Problem Codes	Contamination (1120); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A biomérieux internal investigation was performed.A vessel was visually inspected, and a plastic split on the first well of the vessel was observed.The investigation with the supplier determined there was an issue either during inspection of the pieces or during transportation of packaged disposables.As a corrective action, the supplier will update the packing handling symbols on the outer boxes of the nuclisens® easymag® disposable in order to implement a careful handling of the products during shipment.In addition, the supplier will dispense a specific training to the teams working at each step of the nuclisens® easymag® disposable manufacturing.The goal will be to clarify the nonconforming products detection and the appropriate actions to implement during manufacturing.
Event or Problem Description
A customer in (b)(6) reported a leakage problem with the nuclisens® easymag® disposable (lot z108gb).The customer stated they observed a perforation on one disposable vessel, and there was leakage in the last well of the vessel.The customer could not confirm if other vessels were affected, as not all vessels were filled.The customer discarded the impacted vessel and no longer had the lot.There is no indication from the laboratory that the issue led to discrepant results or adverse events related to any patient, nor any report that the leaking vessel led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents.

• Brand Name: NUCLISENS® EASYMAG® DISPOSABLE
• Common Device Name: NUCLISENS® EASYMAG® DISPOSABLE
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des berges; grenoble cedex 01, 38024 ; FR 38024
• MDR Report Key: 7294058
• Report Number: 3002769706-2018-00023
• Device Sequence Number: 13765661
• Product Code: JJH
• UDI-Device Identifier: 03573026139360
• UDI-Public: 03573026139360
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: CL 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 280135
• Device Lot Number: Z108GB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1