• 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 14000
Device Problem Insufficient Information
Event Date 03/28/2014
Event Type  Injury  
Event Description

The customer's mother reported that the pod was activated at 10:44 am on (b)(6) 2014. The customer's blood glucose was 400 mg/dl, and the customer had just eaten 50 grams of carbohydrates, so he bolused 17 units of insulin. At 3:30 pm, the customer has low blood glucose levels and had a seizure. He fell over and was unconscious. He was taken to the er by ambulance. The customer was hospitalized for 48 hours. The doctor was having difficulty bringing the customer's blood glucose level up out of the 30's-40's (mg/dl), so he removed the pod. The customer was treated with iv glucose. He also suffered injuries during his fall and obtained a cracked occiput, 2 small brain contusions, and a small epidural hematoma. The customer has no memory of the event. The pod was discarded.

 
Manufacturer Narrative

The device was discarded and will not be returned for evaluation. We are unable to determine if any malfunction or other product condition could have contributed to the reported hospitalization and hypoglycemia. Lot 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 CORPORATION
bedford MA
Manufacturer Contact
michael doyle
9 oak park dr.
bedford , MA 01730
7814575000
MDR Report Key3800200
Report Number3004464228-2014-00556
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40887
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/31/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/28/2014 Patient Sequence Number: 1
-
-