MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER SENSOR, GLUCOSE, INVASIVE

Model Number MMT-XXX

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 08/16/2017

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 they were hospitalized on (b)(6)2017 due to high blood glucose level of 320 mg/dl. The customer stated they were calling from a hospital to make sure that their insulin pump is working correctly but the customer was not wearing the insulin pump and did not have the insulin pump with her during the call for troubleshooting the issue. The customer stated they would call back to troubleshoot for the high blood glucose reading and the insulin pump. The insulin pump will not be returned for analysis.

• Brand Name: OTHER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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: 6849012
• MDR Text Key: 85145921
• Report Number: 2032227-2017-45436
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/07/2017 Patient Sequence Number: 1