MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G WITH ENLITE ARTIFICIAL PANCREAS DEVICE SYSTEM

Model Number MMT-551NAB

Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)

Patient Problems Fall (1848); Hypoglycemia (1912); Injury (2348)

Event Date 04/22/2017

Event Type  Injury  

Event Description

I experienced a hypoglycemic event on (b)(6) 2017 in which i experienced an accidental fall which led to multiple traumatic injuries that required emergency medical treatment in addition to receiving emergency dental care. It has been extensive, and i'm still receiving continuous treatment regularly. The cause of this incident could be from the medtronic urgent medical device recall for potential over-delivery of insulin. On that day, i refilled my minimed reservoir, and inserted a new minimed cannula, which is the device being recalled due to defects, prior to my departure. Also the enlite sensor for the medtronic minimed 530g wasn't functional on that date, which ultimately would have prevented this traumatic event by making aware of my glucose levels which would have provided me with the warning that would have led to me taking the appropriate steps to preventing this event from occurring.

• Brand Name: MINIMED 530G WITH ENLITE
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6903614
• MDR Text Key: 87857441
• Report Number: MW5072532
• 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: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/29/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device EXPIRATION Date: 02/24/2017
• Device MODEL Number: MMT-551NAB
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 09/29/2017 Patient Sequence Number: 1