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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Renal Failure (2041); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 1005 mg/dl while wearing the pod.Symptoms reported include hyperglycemia, shortness of breath and high ketones.Spouse reported patient had a stroke while in the emergency room and was placed in the intensive care unit for the first 3 days of hospitalization.Patient also experienced hypertension and kidney failure.Patient was then put on a respirator, ventilator, treated with an insulin drip, given dialysis every other day with a catheter, and given high blood pressure medication.Spouse reported patient was in a diabetic coma as well.The patient was also prescribed the medications listed below.The patient was released after spending 11 days in the hospital.The pod was removed and discarded at the hospital.The list of medications prescribed to the patient is as follows: medication strength frequency: pantoprazole 40mg, norvasc 5mg daily, folic acid once daily, calcium magnesium 1250mg once daily, albuterol 3ml every 6 hours, admelog insulin for pod.

• 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: 10931065
• MDR Text Key: 220470512
• Report Number: 3004464228-2020-18628
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/01/2020
• 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): Hospitalization
• Patient Age: 57 YR