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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Staphylococcus Aureus (2058)

Event Date 05/05/2020

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.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide.Model: ust400.17845-5a-aw rev b 09/17.Changing your pod.Chapter 3 / page 24.Warnings: never use insulin that is cloudy; it may be old or inactive.Check the insulin manufacturer¿s instructions-for-use for the expiration date.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 34.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 you observe blood in the cannula, check your blood glucose frequently to ensure that insulin delivery has not been affected.If you experience unexpectedly elevated blood glucose levels, change your pod.If an infusion site shows signs of infection: immediately remove the pod and apply a new one at a different site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes.Chapter 11 / page 115.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 you suspect an infection, immediately remove the pod and apply a new pod in a different location.Then call 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 that a patient developed an infection at the pod¿s insertion site while wearing the device for more than 48 hours on the arm.The patient was taken to the open door clinic and diagnosed with cellulitis and a staph infection.The patient was lanced and the site was drained and the patient was given two types of penicillin.

• 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: 10066444
• MDR Text Key: 191607763
• Report Number: 3004464228-2020-07125
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 05/05/2020
• 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): Required Intervention
• Patient Age: 61 YR