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

Model Number MMT-7008A

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 400 mg/dl and the sensor glucose was 60 mg/dl at the time of the incident. Customer treated high blood glucose with the insulin pump and declined troubleshooting for it. Sensor glucose and blood glucose was 340 mg/dl. Troubleshooting was done and customer stated that their blood glucose and sensor glucose levels were not in acceptable range. Sensor glucose was lower than blood glucose. Insulin delivery was suspended due to sensor glucose values. Sensor glucose value that triggered the suspend event was 60 mg/dl. Suspend on low limit in sensor settings was 90 mg/dl. Customer advised to monitor and change sensor if issue persists. The device 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: 7532538
• MDR Text Key: 108848792
• Report Number: 2032227-2018-03705
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/23/2018
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: K247P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/24/2017
• 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: 05/22/2018 Patient Sequence Number: 1