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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 Unintended Movement
Event Date 10/04/2016
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

It was reported that the patient's blood glucose level reached high (>500 mg/dl) while wearing the pod longer than 48 hours. The patient stated that the cannula was dislodged from the insertion site.

 
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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
suite 200
billerica MA 01821
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
MDR Report Key6066215
Report Number3004464228-2016-03440
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation Patient
Type of Report Initial
Report Date 10/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date12/14/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL42510
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/15/2016
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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