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 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

A not reportable initial mdr assessment was determined on 8/5/2015 for the complaint received on 7/15/2015.The complaint sample (omnipod) was returned to insulet complaint department on 07/28/2015.Upon completion of the device investigation, it was found evidence of an internal leak.Its root cause was determined to be a "damaged cannula" ((b)(6) 2015).As a result of identifying this failure mode with the original complaint, it is now a reportable adverse event.Lot 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 provider.".

Event Description

The customer reported at 10:31 am her blood glucose measured 401 mg/dl after wearing the pod was less than 4 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
• 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: 5022124
• MDR Text Key: 23835653
• Report Number: 3004464228-2015-00606
• 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: 07/15/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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 Age: 58 YR