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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was returned but evaluation has not been performed at this time.Follow up mdr required to report results.

Event Description

It was reported that a patient developed an infection at the pod¿s insertion site while wearing the device between 36 and 48 hours.The patient also experienced high bg levels of 423 mg/dl.The patient was taken to the emergency room and diagnosed with a staph infection.The patient was treated with a rx of cephalexin.Patient did not feel better the next day so she went back and received a prescription for doxycycline, sulfameth and mupirocine.Patient also had the infected site drained.

Manufacturer Narrative

The returned product was evaluated and performed as designed.No issues were found that would result in an infected site.The pod was found to have completed sterility within specification.

• 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; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 7849670
• MDR Text Key: 119324320
• Report Number: 3004464228-2018-05753
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)180329(17)190929(10)L43771
• 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
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2019
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L43771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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: 36 YR