MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC MINIMED; INSULIN PUMP

Model Number 530G

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/31/2017

Event Type  Injury  

Event Description

Medtronic 530g insulin pump has been suspending insulin for prolonged periods of time without alerting patient.

• Brand Name: MEDTRONIC MINIMED
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC; northridge CA 91325
• MDR Report Key: 6995773
• MDR Text Key: 90932318
• Report Number: MW5073078
• Device Sequence Number: 0
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 530G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 18 YR
• Patient Weight: 65