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

Model Number 14000

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the bent and dislodged cannula or to determine if it could have contributed to the reported hyperglycemia.However, 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.Omnipod insulin management system ¿ user guide.Model: ust400.17845-5a-aw rev b 09/17.Checking your blood glucose.Chapter 4 / page 36.Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.

Event Description

It was reported that a patient's blood glucose levels reached 320 mg/dl while wearing the pod longer than 48 hours.During the night, the pod adhesive was loose and thus, cannula dislodged from the infusion site (arm).It was also noted, that the cannula was inspected and was bent.As treatment, a bolus was delivered and a new pod was applied immediately after the event.

• 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 ; 9786007000
• MDR Report Key: 7658173
• MDR Text Key: 113010078
• Report Number: 3004464228-2018-04079
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)170424(17)181024(10)L43071
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2018
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L43071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• 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