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

Model Number MMT-7008A

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 06/08/2017

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 that she is experiencing low blood glucose.She said that she is on vacation and her pump was reading 148 mg/dl.She said that she was feeling nauseous and checked her blood glucose and her blood glucose was 34 mg/dl.At night, her sensor told her that she was 40 and she checked her blood glucose and it was 120 mg/dl.The customer stated that she corrected her low blood glucose with food.She said that what led up to the problem was that, while on vacation, she had been walking a lot so she believes that is what attributed to her low blood glucose.During troubleshooting for low blood glucose, she was not sure if their insulin type and concentration was correct based on the doctor¿s orders.She was also unsure if their pump¿s programming was accurate.Customer declined sensor glucose versus blood glucose troubleshooting.She also declined troubleshooting for high blood glucose.The sensor and the insulin pump will not be returning 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: 7603684
• MDR Text Key: 111141737
• Report Number: 2032227-2018-05892
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 78