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

Model Number 14000

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Hyperglycemia (1905)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Time: 1:50 pm, blood glucose (mg/dl): 283.Time: 3:00 p.M, blood glucose (mg/dl): 324.Time 3:55pm, blood glucose (mg/dl): 294 - pod deactivated.The customer's mother reported that the needle deployed 10 minutes after it was supposed to.

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure to fire and properly deploy or to determine its root cause.Lot qualification records were reviewed and the product lot met all acceptance criteria.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; billerica MA
• Manufacturer Contact: michael doyle ; 600 technology park dr. suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 4189290
• MDR Text Key: 15807672
• Report Number: 3004464228-2014-01459
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40929
• Other Device ID Number: 0013490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 12 YR