MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Death (1802); Renal Failure (2041)

Event Date 03/01/2016

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 in the emergency room of a hospital.The customer was hospitalized on (b)(6) 2016.The caller stated that the paramedics were called and the customer was transported by an ambulance because the customer passed out.The caller stated that the cause of death was diabetic cardiac arrhythmia, diabetic hyperkalemia, and diabetic sis.The caller did not know the customer's blood glucose at the time of death.The caller stated that they are unsure whether the customer was wearing the insulin pump at the time of death or not.The customer used sensors, however, the caller was unsure whether a sensor was worn at the time of death or not.The customer had kidney failure.The caller stated that currently they do not have the customer's insulin pump or any other diabetes products; however, they agreed to return the insulin pump for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 7594163
• MDR Text Key: 110843280
• Report Number: 2032227-2018-05290
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 66