MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number 18239

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417); Loss of consciousness (2418)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms."high blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.Beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626.Welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755.Puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158".

Event Description

It was reported that a patient had been hospitalized with diabetic ketoacidosis (dka).The patient reported that they passed out on thursday (b)(6) 2022 and was found on friday evening in a diabetic coma.The patient reported that their blood glucose (bg) levels were 800 mg/dl.The patient was take to the intensive care unit (icu) and was treated with intravenous therapy with fluids and an insulin drip.They were also given blood pressure medication.The patient was currently still in the icu.When they reviewed the pdm history it seemed that it was not correctly providing them with insulin for an unknown reason.

Manufacturer Narrative

In the case description, the user reports experiencing a medical event and being treated for dka while the pdm was in use.It was also reported that the pdm insulin history shows no basal insulin was delivered between 13april2022 and 16april2022.Inspection of the pdm history confirmed that no basal insulin was recorded from 13april2022 to 15april2022.The pdm history also showed that a pod was activated on 12april2022, and no basal program was recorded to have started after activation.This pod was active for all three days where the basal insulin was not recorded.Investigation also found that no basal insulin was recorded within the.Ibf file either.Analysis of the android log files from the returned device show that after the new pod was activated on april 12th, the pod was active and running a basal program for the entirety of the pod run until its deactivation on april 16th.The android log files are the true and correct data source for pdm operation, verifying that basal insulin was being delivered during operation despite not being recorded in the pdm history.The android log files and the pdm history show the pod was deactivated due to an alarm with reference number (b)(4).No pdm alarms were observed on the date of occurrence or the days leading up to the date of occurrence.During investigation, the pdm was successfully paired with a pod and completed delivery testing without issue.It was observed in the pdm history that a basal program was successfully started after activation was complete and basal insulin was successfully recorded.No issues were observed with the pdm being able to deliver insulin.It could not be conclusively determined what caused the basal insulin issue or if the incorrectly recorded basal insulin values contributed to the reported event.

• Brand Name: OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
• 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 14192780
• MDR Text Key: 289963878
• Report Number: 3004464228-2022-06647
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009(11)190814(17)230316(10)L000365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2023
• Device Model Number: 18239
• Device Catalogue Number: USA1-D001-MG-USA1
• Device Lot Number: L000365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female