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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Pneumonia (2011); Vomiting (2144)

Event Date 11/03/2021

Event Type  Injury  

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.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels reached 740 mg/dl and the ambulance transported the patient to the hospital.Symptoms reported include high blood glucose and vomiting.The patient was treated with insulin via intravenous therapy.The pod was removed and discarded at the hospital.The patient was diagnosed with pneumonia and intestinal flu.The patient was discharged after 10 days.

Manufacturer Narrative

Health effect- impact code from f12 serious injury/ illness/ impairment to f08 hospitalization or prolong hospitalization.

• Brand Name: OMNIPOD 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: 12881820
• MDR Text Key: 281316167
• Report Number: 3004464228-2021-21247
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

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 Model Number: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization