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

Model Number 18325

Device Problems Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 02/16/2023

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 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 went to the hospital and was diagnosed with blood glucose (bg) values reached 311 mg/dl.The patient was also diagnosed with gastritis.The patient had ketones, pain, was nauseous and vomiting.For treatment, the patient was given zofran, fluids and insulin and diagnostic tests.The patient was discharged after 8 hours.The pod was worn between 4 and 24 hours on the leg.

Event Description

It was reported that the patient went to the hospital and was diagnosed with blood glucose (bg) values reached 311 mg/dl.The patient was also diagnosed with gastritis.The patient had ketones, pain, was nauseous and vomiting.For treatment, the patient was given zofran, fluids and insulin and diagnostic tests.The patient was discharged after 8 hours.The cannula was bent, while wearing the pod between 4 and 24 hours on the leg.

Manufacturer Narrative

Remove from emdr-131482.B5 - describe event or problem = it was reported that the patient went to the hospital and was diagnosed with blood glucose (bg) values reached 311 mg/dl.The patient was also diagnosed with gastritis.The patient had ketones, pain, was nauseous and vomiting.For treatment, the patient was given zofran, fluids and insulin and diagnostic tests.The patient was discharged after 8 hours.The pod was worn between 4 and 24 hours on the leg.Remove from medical device problem code = a26 insufficient information.Remove from component code = g04105 pump.Add to medical device problem code = a040609 material twisted/bent.Add to component code = g04019 cannula.Add to b5 - describe event or problem = it was reported that the patient went to the hospital and was diagnosed with blood glucose (bg) values reached 311 mg/dl.The patient was also diagnosed with gastritis.The patient had ketones, pain, was nauseous and vomiting.For treatment, the patient was given zofran, fluids and insulin and diagnostic tests.The patient was discharged after 8 hours.The cannula was bent, while wearing the pod between 4 and 24 hours on the leg.

• 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: 16427763
• MDR Text Key: 310070854
• Report Number: 3004464228-2023-05198
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000051
• UDI-Public: (01)20385082000051(11)220414(17)231014(10)PD1U04142213
• 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: 02/21/2023

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: 10/14/2023
• Device Model Number: 18325
• Device Catalogue Number: BLE-P1-525
• Device Lot Number: PD1U04142213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male