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

MAUDE Adverse Event Report: INSULET CORP 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 CORP OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14000
Device Problem Failure to Adhere or Bond
Event Date 09/09/2014
Event Type  Injury  
Event Description

The customer's mother reported on (b)(6) 2014 her daughter's blood glucose history is as follows: time: 2:18pm, bg(mg/dl): 300, time: 11:43pm, bg(mg/dl): 383. She stated that the pod was not sticking to her skin while she was at school. She was having chest pains and trouble breathing so she took her to the emergency room. She also mention that the pod was not sticking to her skin. She stayed at the emergency room for about 12 to 13 hours before they finally got her ketone levels down and she was feeling better.

 
Manufacturer Narrative

The product was not returned for evaluation. We are unable to determine if any defect could have contributed to the reported adhesion issue, hyperglycemia and hospitalization. Qualification records were reviewed and the product lot met all acceptance criteria.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORP
bedford MA
Manufacturer Contact
michael doyle
600 technology park drive
ste 200
billerica , MA 01821
9786007000
MDR Report Key4196364
Report Number3004464228-2014-01510
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41234
OTHER Device ID Number0501108
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-