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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC INFUSION SET

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MEDTRONIC MEDTRONIC INFUSION SET Back to Search Results
Device Problems Partial Blockage (1065); Nonstandard Device (1420); Failure to Deliver (2338)
Patient Problems Arrhythmia (1721); Death (1802); Diarrhea (1811); Fever (1858); Hyperglycemia (1905); Nausea (1970); Seizures (2063); Vomiting (2144); Complaint, Ill-Defined (2331); Diabetic Ketoacidosis (2364); Coma (2417); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 08/12/2017
Event Type  Death  
Event Description
My sister was found dead on my kitchen floor on (b)(6) 2017.Unknown to her or i at the time, she was using the "now" recalled medtronics infusions sets, that are reportedly faulty, in that they may not allow insulin to be administered, or (it appears) for insulin to be administered in a large dose, due to blockages on the infusion set.She was ill on (b)(6) from food poisoning, in her thoughts, vomiting and diarrhea throughout the night and am of (b)(6).She contacted me and reported feeling very badly, and wished for a supply of ginger ale (she thought would settle her stomach, and allow her to keep something down, and to help with intestines to stop diarrhea.I arranged for her to get ginger ale and kaopectate and pepto bismol, and some tylenol, which she also requested since she also said she felt feverish/flushed.Later through the day of the (b)(6) she was reporting that she felt as bad as she'd ever felt, and was concerned, and reported that her blood sugar was keeping going up, despite not eating, and only being able to keep a little ginger ale and water down for the whole time.She reported she took three pepto bismol swigs (some maybe thrown up), and had some reduction in bowel movements (diarrhea), but still had terrible feelings, nausea and vomiting.She was concerned about the blood sugar not being regulated, and rising from the a.M.Apparently.She reported she gave herself a bolus of 21 units in the afternoon, and it was not still having an effect on her sugar, and she appeared, in text, quite concerned.I asked her what her sugar was, ketones? and how much insulin she'd taken, and whether she'd gotten any other relief.She reported the 21 units, only.Later she seemed confused.On the a.M.Of (b)(6) 2017 she was found dead on the floor of my kitchen, and had rigor mortis and some body fluid from mouth, which reportedly was frothy/ blood tinged.The scene showed some profound body movements from what looked like her last living moments probably sitting at the kitchen table.There were substantial amounts of blood stick testing devices, and injection apparatus and the reservoirs for the infusions sets/pump etc.We found the pump after the coroner took her body, and it appeared initially that she had input commands for it to administer boluses of 15 units repeatedly for at least 4 times.After contemplation, though, and learning weeks later of the broken infusion sets, it is more likely that she suspected the pump wasn't working and she was trying to see it pump out insulin, and gave it max commands.I am serious doubting that she'd give herself a three day dose of insulin, so it is doubtful that she had the pump connected during that time.The 21 units given much earlier that she reported to me, seems more legit, that she tried to give it, but seems to understand it may not have been injected/administered since she got no metabolic response - and even a little rise after supposedly giving that command to give the bolus.It would seem that she should also have been getting the daily programmed dose which was in the range of 35 units over the day.The pump was not with her body, but found at the foot of the couch in the adjoining room, around her body, there appeared to be some large movements, perhaps in confusion or seizure like activity, in her final movements before unconsciousness and death.The chairs were spilled, and water and milk spilled, and chairs were askew as if maybe she tried to hold on to them before collapsing.The instruments of the insulin infusion sets were on the table as were the testing and insulin supply.We understand the medtronics company knew or suspected this problem as early as april of 2017, and never notified its users, until it came up with a massive campaign to send out a small supply of new units and the warnings and instructions, in september of 2017.We got notice and new infusers on doorstep, 2 weeks after she was dead - where notice to use alternatives would have saved her life.None known - blood sugar tests on home apparatus and infusion sets of medtronics.Autopsy is incomplete still.The food sample was tested and did test positive for evidence of staphylococcus, so whether the sickness was really from food poisoning or from hyperglycemia, or metabolic acidosis or a combination.It is clear the infusion set did not work to infuse the insulin which is likely the cause of confusion, sickness, mental status changes, ketoacidosis, metabolic acidosis, and perhaps seizures, coma, and arrhythmias.The specific cause of death and amounts of insulin, acidemia, ketones, sugar, and other elements will hopefully be part of the autopsy findings.We did report the pump readings at first to coroner, assuming they were amounts given, and thought too much insulin.Now it seems that likely she was not given any, or enough due to the faulty medical infusion sets of medtronics.Whether she had the pump attached or was just trying to prove it was pump, when she was trying those max boluses, is a mystery, and how her thought process worked is too.The blood sugar rising in the a.M.And early afternoon with no diminishment proves it wasn't working, and the bolus command of 21 units she reported she gave seems to have not been administered either (or there'd be some reaction in the blood sugar numbers).Carry out salad was possibly contaminated with staphlococcus.Manufacturer/compounder: (b)(6).Http://medtronicdiabetes.Com.
 
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Brand Name
MEDTRONIC INFUSION SET
Type of Device
MEDTRONIC INFUSION SET
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6906687
MDR Text Key88008627
Report NumberMW5072541
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Weight64
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