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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 07/30/2015

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 reported hyperglycemia and er visit.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod¿s user guide warns "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.

Event Description

The patient's father reported that his child had to go to the er due to heavy breathing, lack of appetite and weakness.At the hospital his child was diagnosed with high blood glucose and was treated with an intravenous therapy of insulin.

Manufacturer Narrative

The returned product was evaluated and performed as designed during testing.No malfunction or other product condition that would have contributed to the patient's hyperglycemia and hospitalization 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
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive suit; billerica MA
• Manufacturer Contact: david simard ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5022087
• MDR Text Key: 23736924
• Report Number: 3004464228-2015-00596
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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): Other
• Patient Age: 10 YR