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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 07/24/2015
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. Lot release and sterilization records were reviewed and the product lot met all acceptance criteria. 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

Customer reported a staph infection at the insertion site and was treated with clindamycin hcl 300mg once by mouth for 10 days.

 
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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 Key5029573
Report Number3004464228-2015-00649
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/31/2015
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 EXPIRATION Date11/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41752
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/15/2015
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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