MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/28/2019
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 via phone call that the customer passed away in an accident.The cause of death was a brain hemorrhage.The caller did not state whether the customer had any illnesses that may have led to the customer's passing.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.No further information was provided.The caller declined to return the insulin pump for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9276407
• Report Number: 2032227-2019-112730
• Device Sequence Number: 16179479
• Product Code: OYC
• UDI-Device Identifier: 00643169221536
• UDI-Public: (01)00643169221536
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A000290552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVRUNOMED SET
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Weight: 182