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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Renal Failure (2041); Diabetic Ketoacidosis (2364); Coma (2417); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned/received to date.If 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.For your reference, insulet modified our internal investigation finding codes effective 25 may 2020 as part of an effort to improve the classification of findings to improve the power of trending data and make the findings more intuitive.The new findings codes will use the system of finding category (e.G.Hardware component), followed by the affected component (e.G.Needle), followed by the condition (e.G.Bent).Therefore you may notice findings that appear to be new or different but in fact are just renamed for improved data value.Insulet would be happy to explain any mapping of the old to new finding codes if you have any questions.

Event Description

It was reported that a patient went to the emergency room (er) by ambulance and was diagnosed with diabetic ketoacidosis (dka).The patient's blood glucose values reached over 1000 mg/dl.The patient was reported to be in a coma, when found at home.For treatment, the patient was put on dialysis for kidney failure, put on a ventilator, and given insulin at 40 units a day.The daughter stated that the history showed a pod was not worn close to 24 hours.The patient had blood work conducted on them and was admitted to the intensive care unit (icu).

Manufacturer Narrative

Data downloaded from the device indicates an 0x6a occlusion alarm occurred during the run.Physical inspection found no damages or defects that would contribute to an occlusion.

• Brand Name: OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10241915
• MDR Text Key: 197969981
• Report Number: 3004464228-2020-10866
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)190503(17)201103(10)PD1C05031921
• Combination Product (y/n): N
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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 Expiration Date: 11/03/2020
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C05031921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR