MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problems Defective Component (2292); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

High blood sugars; starting in november, all through december my pods through omnipod continue to fail and not provide me my insulin.I have had up to five pods in three days fail.This makes it so that i do not receive my proper insulin, waste my medication and have constantly high blood sugar readings and i have kidney failure, so it makes that situation much worse.Fda safety report id # (b)(4).

• Brand Name: OMNIPOD
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 11163265
• MDR Text Key: 227023639
• Report Number: MW5098790
• Device Sequence Number: 4
• Product Code: NBW
• 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: 01/09/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 75