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

Model Number 14000

Device Problem Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The customer reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod user guide warns "check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify that there is no wetness or scent of insulin, which 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 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results that fall above 250 mg/dl, follow the treatment advice of your healthcare provider.".

Event Description

It was reported that the patient's blood glucose level reached high (>500 mg/dl) while wearing the pod longer than 48 hours.The patient stated that the cannula was dislodged from the insertion site.

• 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; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821
• MDR Report Key: 6066215
• MDR Text Key: 58745237
• Report Number: 3004464228-2016-03440
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)160615(17)171214(10)L42510(21)
• 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: Patient
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2017
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L42510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Date Device Manufactured: 06/15/2016
• 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: 8 YR