MAUDE Adverse Event Report: ACCU-CHECK TENDER II MINI INF, 13MM; INFUSION SET

Device Problems Kinked (1339); Use of Device Problem (1670); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

I am using the t-slim insulin infusion pump.I have used several different insulin pumps for approximately 20 years.Over the past year, i have noticed my infusion sets have had to be replaced more often.Sometimes as many as 4 times a day.I use the accu-check ultraflex 1 infusion set(31 inch, 10mm) and the accu-check tender ii mini infusion set (31 inch, 13mm).I use several different areas-abdomen, butt, and recently the inner thighs.It makes no difference where the infusion sets are put.After insertion, my blood sugars will start to rise.I have not eaten any carbs, but still the blood sugars rise.I notice when i change the infusion sets, most of the time the end of the cannula is crimped.The longest i have been able to wear the infusion sets is 12 hours.In the past i have been able to wear them as long as 3-4 days.I do wear a dexcom g4 continuous glucose monitor, so i am alerted when my blood sugars are rising.Dates of use: 1 year.Diagnosis or reason for use: use with my insulin pump to infuse insulin-still using.

• Brand Name: TENDER II MINI INF, 13MM
• Type of Device: INFUSION SET
• Manufacturer (Section D): ACCU-CHECK
• MDR Report Key: 4570408
• MDR Text Key: 18628559
• Report Number: MW5041149
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 77