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); Fever (1858); Hyperglycemia (1905); Unspecified Infection (1930); Renal Failure (2041)

Event Date 02/23/2020

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 and hyperglycemia.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 a patient had been put on hospice a week before the time of the original call, according to the caller.The caller stated that the patient's blood glucose (bg) level was 560s mg/dl, however the date of this reading was not provided.It was reported that the patient got up in the morning and there bg was sky high.The hospice told the caller that the patient's kidneys were shutting down.The patient was running a fever on thursday (b)(6) 2020, so they figured something was happening with her kidneys.They figured she must have an infection somewhere as well.The patient was given antibiotics, and the fever got down to 99.5 degrees fahrenheit.Breathing started to become difficult for the patient.The patient passed away soon after.The patients health history was as follows: patient was diagnosed with dementia (b)(6) 2019; and around (b)(6) 2019, the patient had a stroke.The patient's kidneys started to shut down, then affected her other organs.Patient has had a fever since thursday, (b)(6) 2020, and it was 101 degrees.Her bg levels were also high.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 9871731
• MDR Text Key: 184656115
• Report Number: 3004464228-2020-04160
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• 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: 66 YR