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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Post Traumatic Wound Infection (2447)

Event Date 10/19/2018

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 and sterilization records were reviewed and the product lot met all acceptance criteria.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 between 24 and 36 hours (abdomen).The patient was taken to the emergency room and diagnosed with staphylococcus.The patient was treated with sulfaetrim liquid antibiotic 12.5 (mg).

Manufacturer Narrative

Investigation results found no evidence of any damage or manufacturing deficiencies that would cause irritation or infection at the infusion site.The soft cannula and formed needle were inspected and no abnormalities were found.No issues were observed that would contribute to the reported bg (blood glucose) levels, or a failure of the pod¿s ability to deliver insulin.

• 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: 8171247
• MDR Text Key: 130610226
• Report Number: 3004464228-2018-08849
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)180629(17)181229(10)L44003
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/29/2018
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L44003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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): Required Intervention
• Patient Age: 6 YR