MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Sepsis (2067)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 customer was in emergency room due to high blood glucose, urinary tract infection and diabetic ketoacidosis on (b)(6) 2019 with blood glucose level was above 526 mg/dl. The customer was assisted with troubleshooting declined for high blood glucose. The customer was treated with intravenous insulin and then subcutaneous insulin for high blood glucose. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer reports they did not contact their health care professional regarding the high blood glucose. Customer stated that the caller primed the tubing halfway and wanted to know how completely fill it and saw a bubble in the reservoir. Customer stated that approximate size of air bubbles was bigger than a carbonation sized bubble. Customer stated location of air bubble was reservoir. The insulin pump as well as reservoir will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 9388474
• MDR Text Key: 168447396
• Report Number: 2032227-2019-124128
• 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

• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1TC76
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/25/2017
• 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: 11/28/2019 Patient Sequence Number: 1