MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD PERSONAL DIABETES MANAGER; PUMP, INFUSION, INSULIN

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 02/01/2022

Event Type  Injury  

Event Description

I have type 1 diabetes and wear an omnipod insulin pump.Before going to bed around 11pm my blood sugar was 131.I wake up at 5am with my blood sugar over 400 (the glucose monitor read "high").There is no reason for my blood sugar to shoot up this high.I put the necessary insulin and checked my blood before going to bed.I even made sure to not eat a heavy meal before bed as that effects my blood glucose levels.My blood sugar seems to spike up easily one day and then stay at a balanced pace other days with the same amount of insulin.This is not the first time this happens.I am scared of becoming fatally ill as i usually would when going through keto acidosis.If i don't feel better in a few hours i will have to go to the hospital and miss work on top of spending money on hospital bills all because my omnipod isn't working the way it is meant to.It is very scary to wake up with a blood reading of over 400 when i've been doing my part to prevent that.It's almost as if my pump stopped delivering insulin completely.I will be sure to contact omnipod about this as well.Fda safety report id # (b)(4).

• Brand Name: OMNIPOD PERSONAL DIABETES MANAGER
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 13446078
• MDR Text Key: 285149307
• Report Number: MW5107190
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2022
• Patient Sequence Number: 1
• Treatment: NOVOLOG INSULIN
• Patient Outcome(s): Required Intervention; Life Threatening; Disability
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic