MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Cyst(s) (1800); Unspecified Infection (1930)

Event Date 02/09/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod dash insulin management system ¿ user guide.Model: 18320.18296-eng-aw rev b 06/18.Changing your pod.Chapter 3 / page 40.Warnings: never use insulin that is cloudy; it may be old or inactive.Always follow the insulin manufacturer¿s instructions for use.Failure to use rapid-acting u-100 insulin, or using insulin that has expired or is inactive, could put your health at risk.Do not apply or use a pod if the sterile packaging is open or damaged, or if the pod has been dropped after removal from the package, as this may increase the risk of infection.Pods are sterile unless the packaging has been opened or damaged.Do not apply or use a pod that is damaged in any way.A damaged pod may not work properly.Do not use a pod if it is past the expiration date on the package.To minimize the possibility of site infection, do not apply a pod without first using aseptic technique.This means to: wash your hands.Clean the insulin vial with an alcohol prep swab.Clean the infusion site with soap and water or an alcohol prep swab.Keep sterile materials away from any possible germs.Changing your pod.Chapter 3 / page 39.Warnings: check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify that there is no wetness or scent of insulin, which may indicate that the cannula has dislodged.If an infusion site shows signs of infection: immediately remove the pod and apply a new pod at a different infusion site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes.Chapter 13 / page 171-172.Infusion site checks.At least once a day, use the pod's viewing window to inspect the infusion site.Check the site for: leakage or scent of insulin, which may indicate the cannula has dislodged.Signs of infection, such as pain, swelling, redness, discharge, or heat.Warnings: if an infusion site shows signs of infection: immediately remove the pod and apply a new pod at a different infusion site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.If you see blood in your cannula, check your blood glucose more frequently to ensure insulin delivery has not been affected.If you experience unexpected elevated blood glucose levels, change your pod.

Event Description

It was reported by the patient that they were diagnosed with a infection by their doctor.The infection was reported to have settled after 7 days, but a cyst had formed after the infection went away.The patient stated that they were scheduled for a minor surgery to remove the cyst.Also, the patient was prescribed the antibiotic cephalexin for treatment of 500 mg capsules at 1 capsule, 3 times a day for 7 days.The patient was reported to have worn the pod on the upper left arm for about 2 days, when they were bumped playing sports.The patient's blood glucose (bg) values were at 160 mg/dl, when the pod was removed and replaced.

• Brand Name: OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
• 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: 9829059
• MDR Text Key: 189910500
• Report Number: 3004464228-2020-03577
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)190801(17)210201(10)PD1C08011951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180045
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C08011951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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): Required Intervention
• Patient Age: 34 YR