MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® EASY MAG® DISPOSABLE VESSEL

Catalog Number	280135
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a performance issue associated with nuclisens® easy mag® disposable vessel ((b)(4)).The customer reported that the tip was missing from the cartridge after run completion on two (2) different easymags (em 5 and em 9).On both occurrences, the issue was on cartridge position a the second tip position.After the runs completed, the second tip from the left on both affected tip cartridges were missing.The customer reported this lead to a delay in reporting results less than 24 hours, and there no indication or report that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux of a performance issue associated with nuclisens® easy mag® disposable vessel(reference 280135).The customer's issue could not be reproduced due to the fact that the customer had already discarded his defective aspirators, and there were no remaining nuclisens easymag disposable (ref 280135_lot z108hb) available in stock.As no defective samples could be sent to the supplier, the root cause could not be determined.However, the two probable root causes identified are: an inspection issue during the 100% visual control of assembled pieces, or an assembly error that led to a tip detachment after inspection.The system informed the user as expected with a warning/error message.Therefore, the issue was detected and managed correctly.

• Brand Name: NUCLISENS® EASY MAG® DISPOSABLE VESSEL
• Common Device Name: NUCLISENS® EASY MAG® DISPOSABLE VESSEL
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des berges; cedex 01; grenoble, 38024 ; FR 38024
• MDR Report Key: 6969078
• Report Number: 3002769706-2017-00308
• Device Sequence Number: 19119059
• Product Code: JJH
• UDI-Device Identifier: 03573026139360
• UDI-Public: 03573026139360
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 08/28/2018
• Device Catalogue Number: 280135
• Device Lot Number: Z108HB
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1