MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Coma (2417)
Date of Event	12/18/2018
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
It was reported that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2018.The cause of death was anoxic encephalopathy and aspiration pneumonia.The caller stated that the customer had a diabetic coma when they fell, that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of the fall.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected more than 48 hours prior to passing.The customer was not using sensors.The customer's insulin pump got broken when they fell.The caller agreed to return the insulin pump for analysis.Frn-unk-rsvr.Unomed set.
Additional Manufacturer Narrative
The correct information has been included with this report.
Event or Problem Description
It was reported that there was something that happened with the customer but they're unsure if it was the pump.The customer went extremely low and was bleeding from the nose.The customer was wearing the insulin pump at the time of passing.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 8239121
• Report Number: 3004209178-2019-43931
• Device Sequence Number: 2279992
• Product Code: OYC
• UDI-Device Identifier: 00613994743848
• UDI-Public: (01)00613994743848
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2019

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A3523NABJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/05/2019
• 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-RSVR, UNOMED SET,
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Weight: 65