• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14810
Device Problems Activation, Positioning or Separation Problem; Needle
Event Date 07/26/2015
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported failure of the needle mechanism to fire and deploy the cannula or to determine its root cause. Lot released records were reviewed and the product lot met all acceptance criteria. The mylife omnipod user guide warns "check the infusion site after insertion to ensure that the cannula was properly inserted. You should check your blood glucose 1. 5 to 2 hours after each pod change and check the infusion site periodically. If the cannula is not properly inserted, hyperglycemia may result," 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 reported that his blood glucose reached 349 mg/dl and that the needle did not deploy the cannula into the skin.

 
Manufacturer Narrative

The returned device was evaluated and performed as designed. The reported needle mechanism failure was not confirmed. The pod was received with cannula fired and needle fully retracted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5032553
Report Number3004464228-2015-00661
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/01/2016
Device MODEL Number14810
Device Catalogue NumberZXY425
Device LOT NumberL41330
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-