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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 08/18/2016
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. The user reported the the pod fell off while sleeping and that the cannula had come out. 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¿s 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,¿ 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 above 250 mg/dl, follow the treatment advice of your healthcare provider. ¿.

 
Event Description

The customer's mother reported her son's blood glucose reached greater than 300 mg/dl after wearing the pod between 24 and 36 hours. She also reported that the pod fell off while sleeping and that the cannula had come out.

 
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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 Key5948744
Report Number3004464228-2016-02797
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/27/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL42480
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 Received08/18/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/28/2016
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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