MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO

Model Number MMT-751NAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stacking Breaths (1593); Death (1802); High Blood Pressure/ Hypertension (1908)

Event Date 12/10/2016

Event Type  Death  

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

It was reported that the customer passed away at home. The cause of death was coronary artery disease, hypertension and diabetes type 1. The caller stated that the customer had called the paramedics. The caller found the customer slumped over in the bathroom; she was not breathing. The caller stated that they went to bed, and, sometime during the night, the customer was fighting indigestion and had shortness of breath. The caller tried cpr until the paramedics' arrival; however, the customer could not be revived. The caller did not know the customer's blood glucose at the time of death. The customer was wearing the insulin pump at the time of death. The customer was not using sensors. The caller stated that they no longer have the customer's insulin pump. The insulin pump information used on this medwatch report is the last known insulin pump to have been issued to the customer.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6340964
• MDR Text Key: 67727306
• Report Number: 3004209178-2017-91301
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 02/17/2017 Patient Sequence Number: 1