• 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 19191
Device Problems Difficult to Insert (1316); Activation Problem (4042)
Patient Problem Hyperglycemia (1905)
Event Date 11/08/2022
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.It was reported the cannula was possibly not inserted correctly into the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
 
Event Description
It was reported that a patient's blood glucose (bg) levels reached 400 mg/dl while wearing the pod between 1 and 4 hours.Due to elevated bg levels, patient was unsure if the cannula was properly seated in the infusion site.The patient also stated that the pink slide did not move forward.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OMNIPOD INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer (Section G)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer Contact
michael spears
100 nagog park
acton, MA 01720
9786007000
MDR Report Key15906031
MDR Text Key306792580
Report Number3004464228-2022-22453
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385081120033
UDI-Public(01)20385081120033(11)220303(17)230903(10)L72389
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/03/2023
Device Model Number19191
Device Catalogue NumberZXP425
Device Lot NumberL72389
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/09/2022
Initial Date FDA Received12/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age3 YR
Patient SexFemale
-
-