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 Consequences Or Impact To Patient (2199)
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 z108kc).The customer reported receiving error codes for three disposable vessels, while performing whole blood extractions.The customer stated there was an error on the first vessel and during analysis of the second vessel.The customer stated the first vessel was rejected and the extractions were then obtained using wf5.The pcr results were reported as meeting expectations.Later, the customer reported that position one (negative control) leaked from another vessel.The customer indicated that all the issues started in the beginning of the week with the lot.There is no indication from the laboratory that the issue led to discrepant results or adverse events related to the 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.
Additional Manufacturer Narrative
Correction: manufacturing site corrected.Narrative from previous submission: 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 z108kc).The customer reported receiving error codes for three disposable vessels, while performing whole blood extractions.The customer stated there was an error on the first vessel and during analysis of the second vessel.The customer stated the first vessel was rejected and the extractions were then obtained using wf5.The pcr results were reported as meeting expectations.Later, the customer reported that position one (negative control) leaked from another vessel.The customer indicated that all the issues started in the beginning of the week with the lot.There is no indication from the laboratory that the issue led to discrepant results or adverse events related to the 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; 2181 ab hillegom; grenoble cedex 01, 38024 ; FR 38024
• MDR Report Key: 7292889
• Report Number: 3002769706-2018-00021
• Device Sequence Number: 957734
• Product Code: JJH
• UDI-Device Identifier: 03573026139360
• UDI-Public: 03573026139360
• Combination Product (Y/N): N
• 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,Followup
• 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: 09/28/2018
• Device Catalogue Number: 280135
• Device Lot Number: Z108KC
• 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: 08/24/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 02/23/2018
• Supplement 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