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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 10/24/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization for hypoglycemia.No lot release records were reviewed, as the product lot number was not provided.The omnipod user guide warns, "test results below 70 mg/dl mean low blood glucose (hypoglycemia).If you get results below 70 mg/dl, but do not have symptoms of hypoglycemia, repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl, follow the treatment advice of your healthcare provider," and it advises ¿hypoglycemia can occur even when a pod is working properly.Never ignore the signs of low blood glucose (no matter how mild).If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness.If you suspect that your blood glucose level is low, check your bg level to confirm.¿.

Event Description

The mother reported that the patient had a seizure and was admitted to the hospital for hypoglycemia while wearing a pod.She was treated with glucose intravenously.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive suit; billerica MA
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5223373
• MDR Text Key: 31178912
• Report Number: 3004464228-2015-01861
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• 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: 10/26/2015

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: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR