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

Model Number 14500-5N

Device Problem Insufficient Information (3190)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the patient's ketoacidosis and hospitalization.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod user guide warns "test results greater than 13.9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia).If you get results below 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 that fall above 13.9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider," ¿if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death,¿ and 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

The patient's mother reported that her child had to be hospitalized for a day and a half with diabetic ketoacidosis due to the pdm not giving the correct insulin doses.

• 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: derek sammarco ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5434486
• MDR Text Key: 38151753
• Report Number: 3004464228-2016-00611
• 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,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5N
• Device Catalogue Number: ZXY425
• Device Lot Number: L60176
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2016
• Date Device Manufactured: 02/01/2014
• 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