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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 Problems Tube; Unintended Movement
Event Date 07/19/2015
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. The customer reported that the cannula had dislodged from the infusion site. This condition could interrupt insulin delivery and contribute to hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod user guide warns "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 the cannula has dislodged," "because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted," and "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia). If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall above 250 mg/dl, follow the treatment advice of your healthcare provider. ".

 
Event Description

The customer reported that his son铠blood glucose reached 489 mg/dl and his carbohydrate intake and insulin history is as follows: (b)(6). The pod was deactivated and he noticed the cannula was not properly inserted.

 
Manufacturer Narrative

The returned product was evaluated and performed as designed. No defect or deficiency that would result in the cannula failing to insert correctly or the pump failing to deliver insulin was found.

 
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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
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 Key5029953
Report Number3004464228-2015-00658
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41636
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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