MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER MMT-7763NA XMTR US; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7763NA

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

Patient Problem Death (1802)

Event Date 05/18/2018

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 an unknown location.The cause of death was as a result of a car accident.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The caller was unsure if the customer was wearing the insulin pump at the time of death.The caller is unsure if the customer was using sensors.The caller declined to return the insulin pump for analysis.

• Brand Name: TRANSMITTER MMT-7763NA XMTR US
• 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: 7599340
• MDR Text Key: 110992061
• Report Number: 2032227-2018-05582
• 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,other
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7763NA
• Device Catalogue Number: MMT-7763NA
• Device Lot Number: A000450152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2018
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: No
• 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: 32 YR
• Patient Weight: 194