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

Model Number 15880

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 10/27/2020

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 rose above 250 mg/dl while wearing the pod between 4 and 24 hours on the abdomen.Symptoms reported include unresponsiveness.The patient was treated with insulin via intravenous therapy.

Manufacturer Narrative

It was also reported that the patient was treated with ketamine.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10860392
• MDR Text Key: 216855009
• Report Number: 3004464228-2020-17951
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Public: (01)N/A(17)000101(10)UNAVAILABLE
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15880
• Device Catalogue Number: ZXR425
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22 YR