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

Model Number 14000

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Hyperglycemia (1905)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure to fire and the needle did not deploy or to determine its root cause.No product lot number was reported therefore no lot release records were reviewed.The omnipod user guide warns "check the infusion site after insertion to ensure that the cannula was properly inserted.The pdm will automatically remind you to check your blood glucose 1.5 hours after each pod change.If the cannula is not properly inserted, hyperglycemia may result.Verify there is no wetness or scent of insulin, which may indicate the cannula has dislodged," and "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 her blood glucose was high due to the needle did not deploy 20 minutes after activation, her insulin history is as follows: time: 6:51pm, bg(mg/dl): 322, cho(g): 32, bolus(u): 2.30.Time: 7:43pm, bg(mg/dl): 396, bolus(u): 2.10.

• 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 ; 9786007000
• MDR Report Key: 5018096
• MDR Text Key: 23582506
• Report Number: 3004464228-2015-00574
• 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: 07/21/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2015
• 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: 59 YR