MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A NUCLISENS® EASYMAG® DISPOSABLE

Catalog Number	280135
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a customer from the united states notified biomérieux of obtaining a potential contamination when using nuclisens easymag disposable (ref.(b)(4) with emag (ref.(b)(4), serial number: (b)(6).On (b)(6) 2025, the customer performed the extraction of patient sample (plasma) on emag (serial number: (b)(6).The eluate was tested for bkv and the result was positive (130656 iu/ml = 5.08 log10).To be noted that this result is high (same level as the positive control of the run).Internal controls of extraction and amplification were compliant.On (b)(6) 2025, a second extraction was performed of the same patient sample and a new one.This time, both results were negative for bkv.Internal controls of extraction and amplification were compliant.The customer then reanalyzed the extracted eluate on (b)(6) 2025 and again obtained a positive result comparable to the original (119820 iu/ml = 5.12 log10).The extraction logs of emag for on (b)(6) 2025 was analyzed by biomérieux gcs and the runs were compliant.The order of samples in the run report, from vessel to output tubes was verified and are strictly identical.Due to this issue, the customer claimed a delay of a couple of days in the delivery of the results.There is no indication or report from the laboratory that the delayed result led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer from the united states who obtained a potential contamination when using nuclisens easymag disposable (ref.(b)(4)) with emag (ref.(b)(4), serial number: (b)(6)).The complaint analysis did not reveal this issue as a systemic quality issue.Run report and logs provided by customer were analyzed and did not reveal any anomaly.The probable root cause could be an eluate contamination or a human error dispatching the sample.According to the above data, the performance of the nuclisens easymag disposable (ref.280135) are conform to the expected specifications.

• Brand Name: NUCLISENS® EASYMAG® DISPOSABLE
• Common Device Name: NUCLISENS® EASYMAG® DISPOSABLE
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMERIEUX ITALIA S.P.A; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 22522133
• Report Number: 9615037-2025-00028
• Device Sequence Number: 8559906
• Product Code: JJH
• UDI-Device Identifier: 03573026139360
• UDI-Public: 03573026139360
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 06/28/2025
• Device Catalogue Number: 280135
• Device Lot Number: CZ-Z105MN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown