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

Model Number	04541600001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
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.Product was discarded.
Event or Problem Description
It was reported that there is leakage around the pump adapter and infusion set connection.

• Brand Name: ACCU-CHEK TENDER INFUSION SET
• Common Device Name: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9592364
• Report Number: 3011393376-2020-00155
• Device Sequence Number: 374362
• Product Code: FPA
• UDI-Device Identifier: 05705244008502
• UDI-Public: 05705244008502
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 12/01/2022
• Device Model Number: 04541600001
• Device Catalogue Number: 04541600001
• Device Lot Number: 5214617
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 03/18/2020; 03/18/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/30/2020; 03/31/2020
• Patient Sequence Number: 1
• Patient Age: 35 YR