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 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The user reported that the cannula had dislodged from the infusion site and was bent.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 14421-aw rev h 01/16 using the pod 5 / pages 44 - 45 warning: 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.Warning: because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted.Checking your blood glucose 7 / page 96 warning: test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).Warning: if you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia, 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

The patient reported that the pod on her stomach had come loose and her blood glucose levels were rising, reaching 432mg/dl.When she checked the pod, the back part was coming up and she noticed that the cannula was dislodged and bent.The pod had been worn on her abdomen for between 24 and 36 hours.

Manufacturer Narrative

The returned product was evaluated and performed as designed.No bend or kink was observed in the cannula.No issues were observed with the adhesive pad.No defect or deficiency that would result in the cannula failing to insert correctly or the pump failing to deliver insulin was found.

• 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: 7658017
• MDR Text Key: 113002109
• Report Number: 3004464228-2018-04073
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)171018(17)190418(10)L43407
• 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,Followup
• 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: 04/18/2019
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L43407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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: 49 YR