• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MINIMED 530G WITH ENLITE ARTIFICIAL PANCREAS DEVICE SYSTEM Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMINIMED 530G WITH ENLITE
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6903614
MDR Text Key87857441
Report NumberMW5072532
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date02/24/2017
Device MODEL NumberMMT-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
-
-