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

Model Number 15880

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problem Hyperglycemia (1905)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the hyperglycemia.The user also reported that the cannula was out of the infusion site.This condition could potentially interrupt insulin delivery and may lead to hyperglycemia.The omnipod¿s user guide warns to "check the infusion site after insertion to ensure that the cannula was properly inserted.You should check your blood glucose 1.5 to 2 hours after each pod change and check the infusion site periodically.If the cannula is not properly inserted, hyperglycemia may result.Verify there is no wetness or scent of insulin, where as may indicate the cannula has dislodged," "because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted," and "test results greater than 13.9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia).If you get results above 13.9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 13.9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider." it also advises "the pdm will also displays a reminder to check the infusion site and cannula.Make sure the pod is securely attached to your skin.You can see the cannula through the small viewing window on the pod." lot release records were reviewed and the product lot met all acceptance criteria.

Event Description

The customer reported at 5:00 pm her blood glucose was reading at 19.0 mmol/l (342 mg/dl) and that the cannula was not properly inserted and that it was also kinked.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive suit; billerica MA
• Manufacturer Contact: david simard ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5027369
• MDR Text Key: 23932685
• Report Number: 3004464228-2015-00631
• 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,foreign
• Reporter Occupation: Other
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2016
• Device Model Number: 15880
• Device Catalogue Number: ZXR425
• Device Lot Number: L41649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2015
• Date Device Manufactured: 03/15/2015
• 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 Age: 13 YR