MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET UNKNOWN

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Staphylococcus Aureus (2058); Diabetic Ketoacidosis (2364)

Event Date 08/12/2017

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2017 no relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.The claimed failure cannot be confirmed.The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.

Event Description

(b)(4).Fda reference number mw5072541.In (b)(6) 2017 a female diabetic patient was found dead on the kitchen floor.She was ill from food poisoning, in her thoughts, vomiting and diarrhea throughout the night and morning.She contacted her brother 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.He arranged for her to get ginger ale and kaopectate and pepto bismo, and some tylenol, which she also requested since she also said she felt feverish/flushed.Later through the day she was reporting that she felt as bad as she had 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 feeling, nausea and vomiting.She was concerned about the blood sugar not being regulated, and rising from the morning apparently.She reported she gave herself a bolus of 21 units in the afternoon, and it was still not having an effect on her sugar, and she appeared quite concerned.He asked her what her blood sugar was, ketones and how much insulin she had taken, and whether she had gotten any other relief.She reported the 21 units, only.Later she seemed confused.In the morning she was found dead on the kitchen floor 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 infusion sets/pump etc.They 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 was not working and she was trying to see it pump out insulin, and gave it max commands.He is serious doubting that she had given 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 him, 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.None known blood sugar test on home apparatus 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 the 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 finding.They did report the pump reading 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 morning and early afternoon with no diminishment proves it was not working and the bolus command of 21 units she reported contaminated with staphylococcus.

• Brand Name: INFUSION SET UNKNOWN
• Type of Device: INFUSION SET UNKNOWN
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 7107611
• MDR Text Key: 94481125
• Report Number: 3003442380-2017-00022
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening