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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); Diarrhea (1811); Hyperglycemia (1905); Pain (1994); Vomiting (2144); Anxiety (2328)

Event Date 03/09/2023

Event Type  Injury  

Event Description

It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels reached 300 mg/dl while wearing the pod longer than 48 hours.Symptoms reported include shock, dehydration, a magnesium deficiency, a panic attack, vomiting and diarrhea.The patient was treated with fluids via iv, zofran, and benadryl due to the patient being allergic to zofran.The patient also got over the counter magnesium and pepcid.It was also stated that there was pain at the insertion site.The patient was released the following day.The pod was worn when seeking medical attention.

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 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.

• 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: 16668535
• MDR Text Key: 312589160
• Report Number: 3004464228-2023-08763
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)211206(17)230606(10)PD1K12062111
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K12062111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male