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

Model Number 14000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Hyperglycemia (1905)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization for hyperglycemia.Generally adhesion issues are due to variations in skin condition and are not considered malfunctions.No lot release records were reviewed, as the product lot number was not provided.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 provider.".

Event Description

The customer reported that his blood glucose reached 500 mg/dl in which he was hospitalized as a result.He was diagnosed with extreme high bg and treated with manual injection due to the pods adhesive falling off.

• 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 suit; billerica MA 01821
• Manufacturer Contact: david simard ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 5018870
• MDR Text Key: 23607133
• Report Number: 3004464228-2015-00588
• 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: Other
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 39 YR