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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Hyperglycemia (1905); Unspecified Infection (1930); Pain (1994); Skin Inflammation (2443)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to customer's infusion site infection.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient developed an infection at the pod¿s insertion site while wearing the device longer than 48 hours.The pod was removed and patient was taken to the emergency room (er) by mother, where he was diagnosed with cellulitis.Symptoms reported included discharge, inflammation, bleeding and pain; patient also had a blood glucose level between 250 mg/dl and 260 mg/dl.The patient was treated with antibiotics via injection, site was cleaned by doctor and patient was prescribed amoxicillin, to be taken every 12 hours for 7 days.Patient was released after spending a couple of hours in the er.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 10688045
• MDR Text Key: 211642674
• Report Number: 3004464228-2020-16310
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• 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
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 9 YR