MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Inspected 1 opened/used sensor and performed continuity resistance test (b)(4). Sensor passed per specification. Also, performed bicarbonate buffer test. Sensor passed per specifications with accurate readings. See attached file for details.

Event Description

The customer reported via phone call that the blood glucose was high. The customer reported that he had sensor malfunctioned again. The customer reported that it lasts for 4 days. He did insulin for breakfast, it was showing that it was going low. He ate some bars. Pump was suspending insulin and his blood glucose was 480mg/dl. He had several sensor failures, he got it going he had sensor error, he waited for an hour and still not accepted, and started working for few hours but later it was not working still. The customer declined to troubleshoot for high blood glucose. The insulin pump will not be returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7628581
• MDR Text Key: 111981389
• Report Number: 2032227-2018-06978
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/22/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 06/22/2018 Patient Sequence Number: 1