MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751RNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751RNAS
Health Effect - Clinical Codes	Death (1802); Loss of consciousness (2418)
Date of Event	09/19/2017
Type of Reportable Event	Death
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 in an unknown location due to the recalled sets.The customer went to the emergency room after losing consciousness for no reason, falling, and breaking their jaw.The cause of death was unknown.The caller stated that the pump was ok but the sensors were not.The customer¿s blood glucose was unknown at the time of death.It is unknown if the customer was wearing the insulin pump at the time of death.It is unknown if the customer was using sensors.The caller also mentioned possibly getting a lawyer.The caller declined to return the insulin pump for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAS
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7516173
• Report Number: 3004209178-2018-71659
• Device Sequence Number: 19335870
• Product Code: OZO
• UDI-Device Identifier: 00643169508002
• UDI-Public: (01)00643169508002
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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-751RNAS
• Device Catalogue Number: MMT-751RNAS
• Device Lot Number: A3751RNASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 05/15/2018
• 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: Death
• Patient Age: 72 YR
• Patient Weight: 185