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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dehydration (1807); Hyperglycemia (1905)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels rose above 24 mmol/l (>432 mg/dl).Symptoms reported include dehydration and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin and calcium.The patient was released the following day.The pod was removed prior to the hospitalization.

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 hyperglycemia.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.

Event Description

It was reported that the patient visited the emergency room (er) due to hyperglycemia.The patient's blood glucose levels rose 24 mmol/l (432 mg/dl).Symptoms reported include dehydration, irregular heartbeat and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin, fluids and calcium utilizing intravenous therapy.The patient was released the same day.The pod was changed prior to leaving for the er.

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 emergency room visit and hyperglycemia.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.Correction to b2 - outcomes attributed to ae from: hospitalization-initial or prolonged to: required intervention correction to b5 - describe event or problem from: it was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels rose above 24 mmol/l (>432 mg/dl).Symptoms reported include dehydration and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin and calcium.The patient was released the following day.The pod was removed prior to the hospitalization.To: it was reported that the patient visited the emergency room (er) due to hyperglycemia.The patient's blood glucose levels rose 24 mmol/l (432 mg/dl).Symptoms reported include dehydration, irregular heartbeat and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin, fluids and calcium utilizing intravenous therapy.The patient was released the same day.The pod was changed prior to leaving for the er.Correction to h6 - adverse event problem health effect - impact code from: f08 hospitalization or prolonged hospitalization to: f12 serious injury/ illness/ impairment correction to h10 - additional mfg narrative from: 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 hyperglycemia.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.To: 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 emergency room visit and hyperglycemia.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.

Manufacturer Narrative

An internal leak on the unexposed portion of the soft cannula was found, causing corrosion on internal components, insufficient battery voltages and preventing recovery of the device data.Without the data, it could not be determined if the device generated an alarm or if the damaged cannula contributes 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: 16571932
• MDR Text Key: 311567171
• Report Number: 3004464228-2023-07384
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)220322(17)230922(10)PD1K03222221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K03222221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Female