MAUDE Adverse Event Report: MEDTRONIC SILHOUETTE PARADIGM; INSULIN PUMP

Model Number MMT-391

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Cyanosis (1798); Fall (1848); Hypoglycemia (1912); Respiratory Distress (2045); Seizures (2063)

Event Date 08/08/2017

Event Type  Injury  

Event Description

My son changed his insulin set before bed.I checked his glucose level at 1:20 am.At just before 5 am, i heard a thump and then something like a cough.I went to my son's room and realized he had had a seizure and ended up on his back barely breathing through fluid in his mouth.He was completely blue and i can only say i never knew how quickly i could move, but i ran to him, lifted his head off the pillow and pounded his back and tried to get him to breathe deeply enough to get more oxygen.I could see his color was returning, so i ran downstairs to get the glucagon which i administered.After making sure he wasn't in immediate danger, i called the emergency squad and they came to assess him.After an hour or so he was conscious and able to determine where he was so that he didn't elect to go to the hospital.Without a doubt, without intervention he would not be here today.I didn't do everything right, but i managed to do enough right to keep him with us.Medtronic had issued warnings in the past about the problem with this reservoir membrane after set change and they sent out an email today for a recall.I consider it a little late on their behalf, and i'm not completely convinced that this is just a problem immediately after the set is changed.We have had issues with extreme low blood glucose levels that materialize out of the blue.It takes quite a bit to turn the hypoglycemia around so that i feel it may have been quite a bit more insulin being delivered than just a normal basal amount.This event has definitely caused me to question putting complete trust in insulin being administered by a pump.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6861532
• MDR Text Key: 86106767
• Report Number: MW5072117
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-391
• Device Lot Number: 5175691
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 79