MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hyperglycemia (1905)
Date of Event	05/24/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).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 hospital.The customer was hospitalized on (b)(6) 2015.The cause of death was breathing difficulties.The caller stated that the customer had other 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 not wearing the insulin pump at the time of death.The insulin pump had been disconnected more than 48 hours prior to passing, at the time of hospitalization.The caller stated the customer had high blood glucose due to anxiety, but was taken off the pump when they got hospitalized.The customer was not using sensors.The caller declined to return the insulin pump for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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; * 00777-3869
• MDR Report Key: 10330561
• Report Number: 2032227-2020-153080
• Device Sequence Number: 11625867
• Product Code: OYC
• UDI-Device Identifier: 00643169151345
• UDI-Public: (01)00643169151345
• 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
• Report Date (Section B): 07/27/2020

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A3723LNALJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/27/2020
• 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: Death; Hospitalization
• Patient Age: 80 YR