MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. H-TRON PLUS 3.15 ML INSULIN CARTRIDGE; INSULIN INFUSION PUMP ACCESSORY

Catalog Number	05206073001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insulin cartridge leaked insulin into the cartridge compartment of the infusion device.
Additional Manufacturer Narrative
The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: H-TRON PLUS 3.15 ML INSULIN CARTRIDGE
• Common Device Name: INSULIN INFUSION PUMP ACCESSORY
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): CLINICO MEDICAL SP. Z O.O.; ul. roberta kocha 1; na; blonie / miekinia 55-33 0; PL 55-330
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18977141
• Report Number: 3011393376-2024-00712
• Device Sequence Number: 20372216
• Product Code: LZG
• UDI-Device Identifier: 04015630882908
• UDI-Public: 04015630882908
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2025

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: Lay User/Patient
• Device Expiration Date: 01/23/2025
• Device Catalogue Number: 05206073001
• Device Lot Number: 32085603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 07/22/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/29/2024; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN
• Patient Age: 41 YR
• Patient Sex: Female