MAUDE Adverse Event Report: MEDTRONIC SURE T INFUSION SET

Model Number MMT-886

Device Problems Break (1069); High Test Results (2457); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hyperglycemia (1905); Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2015

Event Type  Injury  

Event Description

About a year ago, i had a sure t infusion set's needle break off into me.I thought that it was an anomaly, so i did not report it.I thought that perhaps it was something that i did that was wrong, but over the past two weeks i've been reassured that it might be a product issue.I only recently reported the previous incident and now i am reporting a new one.I am an insulin dependent type 1 diabetic who uses the medtronic insulin pump.On the night of (b)(6) 2015 my blood sugar levels rose to about 350 in the middle of the night.When i changed my infusion set, i noticed the needle was missing.I had to catch a flight to (b)(6) a few hours later, so i left it.I contacted my doctor, who told me it would be fine to leave the needle in there for a while.While walking around in (b)(6) on (b)(6) 2015 my blood sugar levels began rising.I kept giving myself insulin using my insulin pump, but it had no effect.Once my blood sugar levels reached 300 i decided i needed to go back home to give myself an injection.By the time i reached the apartment, i was so sick it was difficult for me to stand up.My blood sugar levels were well over 500 (the meter does not go above that) and i gave myself an injection of humalog insulin.When i removed the sure t infusion set, the needle was once again missing.I returned home on (b)(6) 2015 and immediately went to see the doctor.The radiologist imaged the two sites using x-ray and ultrasound and found the needles to be in my buttocks.We scheduled a surgery for (b)(6) 2015.Images were once again taken on (b)(6) 2015 but the needles were very difficult to track using ultrasound.The images were clear with x-ray but the needles were very difficult to rack using ultrasound.The images were clear with x-ray but ultrasound would have been useful for knowing the depth of the needles.The surgery on (b)(6) 2015 was unsuccessful and the surgeon was unable to find either needle.When i called medtronic they were not helpful.They said they know about this being a problem with the device, but they have no idea what the long term risks would be if i left the needles in there.I asked for advice and they told me they usually just tell patients to go to the doctor, but other than that they don't have anything to say to me.They did not refund me or send me any new infusion sets.They did however tell me that they were sorry this happened.

• Brand Name: SURE T INFUSION SET
• Type of Device: SURE T INFUSION SET
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4785427
• MDR Text Key: 5854806
• Report Number: MW5042772
• Device Sequence Number: 1
• 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: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Model Number: MMT-886
• Device Catalogue Number: MMT-886
• Device Lot Number: 5083296
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2015
• Patient Sequence Number: 1
• Treatment: FREESTYLE LITE BLOOD GLUCOSE METER; HUMALOG INSULIN WITH MEDTRONIC PUMP; DEXCOM CONTINUOUS BLOOD GLUCOSE MONITOR
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 75