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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Nausea (1970); Skin Irritation (2076); Diabetic Ketoacidosis (2364)

Event Date 07/02/2016

Event Type  Injury  

Manufacturer Narrative

The returned product was evaluated and performed as designed.No issues were found that would result in site irritation.The pod was found to have completed sterility within specification.The omnipod¿s user guide warns to "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 above 250 mg/dl, follow the treatment advice of your healthcare provider," and "if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death." it advises ¿the easiest and most reliable way to avoid dka is by checking your blood glucose at least 4¿6 times a day.Routine checks allow you to identify and treat high blood glucose before dka develops.".

Event Description

Patient's parent reported that their child had a reaction to the adhesive (itchy, red, raised bumps) causing the patient to itch the pod off during the night.Unaware that the pod was no longer attached the patient, blood glucose level rose to 479 mg/dl and patient was taken to the hospital.Patient was diagnosed with dka (diabetic ketoacidosis).Patient was prescribed zofran for his nausea.Pod was worn longer than 48 hours.

• 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: 5983649
• MDR Text Key: 55824231
• Report Number: 3004464228-2016-03006
• 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: Patient
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2017
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L42430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR