MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH; PUMP, INFUSION, INSULIN

Device Problems Use of Device Problem (1670); Application Network Problem (2879); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2021

Event Type  Injury  

Event Description

Reporter stated that she had the omnipod dash insulin pump for about a month now and since had issues with the pump.She stated that it is difficult to get hold of anyone in the customer service department who can help.She recently call the customer service for assistant with her pump connection and was badly treated.She stated she constantly have problems with the pump connecting with the manufacturer's network.Reporter suggested that fda should make regulations to bypass manufacturer's network for pump connection.

• Brand Name: OMNIPOD DASH
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 12985533
• MDR Text Key: 282224809
• Report Number: MW5105994
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American