MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® RAPID-D INFUSION SET; SUBCUTANEOUS INFUSION SET

Catalog Number	04541065001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infusion set was leaking at the transfer set resulting in high blood glucose levels between 300 mg/dl - 400 mg/dl.The issue occurred with 3 pieces from the same batch, each one in a row between (b)(6) 2024.
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.

• Brand Name: ACCU-CHEK ® RAPID-D INFUSION SET
• Common Device Name: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): CLINICO MEDICAL SP Z O.O.; ul. kocha 1; na; blonie 55-33 0; PL 55-330
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 20144010
• Report Number: 3011393376-2024-01857
• Device Sequence Number: 15529140
• Product Code: FPA
• UDI-Device Identifier: 04015630046072
• UDI-Public: 04015630046072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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 Catalogue Number: 04541065001
• Device Lot Number: 32341603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose