MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Chest Pain (1776); Death (1802); Nausea (1970); Pneumonia (2011); Virus (2136); Respiratory Tract Infection (2420)

Event Date 07/03/2019

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported death.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide, model: ust400, 17845-5a-aw rev b 09/17.Checking your blood glucose chapter 4 / page 36: warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.

Event Description

It was reported that the caller took the patient to the emergency room (er), on saturday, the (b)(6).According to caller, he had symptoms of a heart attack but neuropathy prevented him from feeling pain in his chest, it was diagnosed as a virus.He was given medications for nausea and vomiting (name of the nausea medication was not provided), antibiotics, motrin, tylenol, inhaler, prevacid (over the counter) & antibiotics (name not provided).According to the caller he was sweating profusely and his head hurt.Caller did not have the names of the medications administered at the er and did not get a copy of discharge papers.The caller did bring the patient to the doctor's office on monday, (b)(6), and he was diagnosed with pneumonia.At the office, patient's bg (blood glucose) was normal, but he had been bolusing to keep it down.The doctor sent the patient for cat scan, and prescribed a different antibiotic for him to take, instead of the one prescribed by the er.He also got instructions to take motrin or tylenol, to keep hydrated, to use an inhaler, and to take pepcid and possibly an anti-nausea medication.The caller had only minimal information on what was prescribed and the instructions to follow.On tuesday, the caller said he was barely eating anything, and drinking large amounts to stay hydrated, including pedialyte that she was serving him.He had nausea that day but less than before.His bg was high again, but she did not have specific numbers to give.On wednesday said he felt a little better, but around 1pm, caller had gone downstairs for something when she heard him yell.She came back upstairs but he was on the floor and was not breathing.She attempted cpr and called the ambulance.The emts (emergency medical technicians) that responded said he did have a very low pulse, and took him to the er after 20 minutes of stabilizing him.At the er, they worked on him for 1.5 to 2 hours but they felt they were just damaging his body at that point so they were going to have to stop their efforts.However at that point, according to the caller, the patient started trying to get up or breathe and the er team turned around and started working on him again.About 10-15 minutes later he passed away.Caller said it was diagnosed as heart attack, a virus, upper respiratory infection, and pneumonia.Treatment provided was resuscitation procedures for heart attack.The patient had been on medication for diabetic neuropathy, but no other medications.The caller stated that the patient was having problems with his bg levels previously, she did not provide any specific bg level.The caller was not sure if the patient was even wearing the pod at this time because she did not look, but she knew he had stopped wearing it in the days before this because his bg had been high even though he was wearing the pod and went down after taking manual injections.She said he probably did wear it but if he did, the er probably took it off.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 8849967
• MDR Text Key: 152905977
• Report Number: 3004464228-2019-07055
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• 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
• Patient Age: 51 YR