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

Model Number	MMT-7763NA
Health Effect - Clinical Code	Death (1802)
Date of Event	05/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the customer passed away at home.The cause of death was unknown.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 customer was wearing the insulin pump at the time of death.The customer was using sensors.The caller did not have further information about the customer's passing.The caller agreed to return the insulin pump for analysis.

• Brand Name: TRANSMITTER MMT-7763NA XMTR US
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7592442
• Report Number: 2032227-2018-05194
• Device Sequence Number: 167493
• Product Code: MDS
• UDI-Device Identifier: 00643169864672
• UDI-Public: (01)00643169864672
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-7763NA
• Device Catalogue Number: MMT-7763NA
• Device Lot Number: A000386936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Weight: 260