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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14000
Device Problem Insufficient Information
Event Date 07/15/2015
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. The omnipod user guide warns "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 and treat the infection according to instructions from your healthcare provider," and advises "check the site for signs of infection, such as pain, swelling, redness, discharge or heat. ".

 
Event Description

The customer reported that her daughter's blood glucose reached 400 mg/dl after patient had swelling around the hard part of device and was not able to touch because of pain. The site was swollen for 10 days. The patient was treated with antibiotic of cephalexin due to an infection.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, 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 suit
billerica MA 01821
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5029748
Report Number3004464228-2015-00651
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number14000
Device Catalogue NumberZXP425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/25/2015 Patient Sequence Number: 1
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