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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 14810
Device Problems Tube; Unintended Movement
Event Date 07/20/2015
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. The customer reported that the cannula dislodged from the infusion site, a condition which could interrupt insulin delivery and contribute to hyperglycemia. The mylife omnipod user guide warns to "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 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," "test results greater than 13. 9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia). If you get results below above 13. 9 mmol/l [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 13. 9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider," and "if your reading is above 27. 8 mmol/l [500 mg/dl], the pdm displays ¿high check for ketones!¿ this indicates severe hyperglycemia (high blood glucose). " lot release records were reviewed and the product lot met all acceptance criteria.

 
Event Description

The customer reported his blood glucose read "high"> 27. 8 mmol/l) (> 500 mg/dl) and that the cannula was out of the skin. The pod was worn between 36 and 48 hours.

 
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
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 
9786007000
MDR Report Key5018826
Report Number3004464228-2015-00581
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/01/2016
Device MODEL Number14810
Device Catalogue NumberZXY425
Device LOT NumberL41408
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/08/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2014
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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