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 03/12/2014

Event Type  Injury  

Event Description

The patient's mother reported on (b)(6) 2014 10:44 pm her daughter activated a new pod.At 2:30 pm, she was throwing up and they decided to take her to the hospital.Upon arrival, she was placed on an intravenous therapy and she was given 5mg of zofen.At 9:22pm, the pod was deactivated and there was no cannula coming out of the pod.The cannula looks as if it had never deployed into the infusion site.

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm the reported failure of the needle mechanism to fire and deploy the cannula or to determine its root cause or to determine if it could have contributed to the reported hyperglycemia and hospitalization.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; bedford MA
• Manufacturer Contact: michael doyle ; 9 oak park dr.; bedford, MA 01730 ; 7814575000
• MDR Report Key: 3763359
• MDR Text Key: 4466129
• Report Number: 3004464228-2014-00453
• 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: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40748
• Other Device ID Number: 0330458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 5 YR