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

Model Number 14000

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Release records were reviewed and the product lot met all acceptance criteria.The omnipod 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 that fall above 250 mg/dl, follow the treatment advice of your healthcare.".

Event Description

Customer's dad reported his son had increased blood glucose levels which reached 330 mg/dl and he did not think the pod was delivering insulin accurately.When the pod was removed he said the cannula looked bent.The pod was worn between 4 and 24 hours.Insulin history is as follows: (b)(6).

Manufacturer Narrative

The device was found to function as intended with no evidence of any damage or manufacturing deficiencies that would have either directly caused or contributed to a deficiency in delivery.A bent cannula was observed, but it is considered to have occurred post use.Had it occurred during use, there would have been pressure build up in the fluid path resulting in a rapid increase in pulse widths and/or an occlusion alarm being generated.No malfunction or other product condition that would have contributed to the reported hyperglycemia 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
• MDR Report Key: 5950680
• MDR Text Key: 54710585
• Report Number: 3004464228-2016-02832
• 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,Followup
• Report Date: 08/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2017
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L42037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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 Age: 7 YR