• 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 15880
Device Problems Tube; Bent
Event Date 07/27/2015
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported bent cannula or to determine whether it contributed to the reported hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod¿s user guide warns "test results greater than 13. 9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia). If you get results 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 above 13. 9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider. ¿.

 
Event Description

The customer reported her blood glucose reached 20. 0 mmol/l (360 mg/dl) and that the cannula was bent to the side.

 
Manufacturer Narrative

The returned product was evaluated and performed as designed. No bent was observed in the cannula. No malfunction or other product condition that would have contributed to reported hyperglycemia was found.

 
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 Key5027376
Report Number3004464228-2015-00632
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
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 Received08/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number15880
Device Catalogue NumberZXR425
Device LOT NumberL41592
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-