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

Model Number	MMT-723LNAP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/28/2018
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.(b)(4).
Event or Problem Description
It was reported via phone call that the customer passed away in hospital on (b)(6) 2019.The customer was hospitalized three weeks prior due to a low blood glucose.The cause of death was reported as multiple reasons related to low blood glucose.The customer's blood glucose was unknown at the time of death.The caller stated that the customer accidentally delivered too much insulin.The customer ran out of insulin during an initial bolus, filled a new reservoir, and administered a secondary bolus which resulted in them delivering too much insulin.The customer experienced a low blood glucose and became semi-unconscious which is when the family called emergency medical services.The caller stated the customer spent three weeks at the hospital in critical care and then passed away due to incorrect actions taken by the hospital.The caller stated the customer did not experience a malfunction with their insulin pump leading up to the passing.The insulin pump was not worn at the time of passing and was removed by hospital staff upon admission three weeks prior.The customer was not using sensors.The caller declined to return the insulin pump as they did not have the device.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• 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: 9658612
• Report Number: 3004209178-2020-63348
• Device Sequence Number: 3392865
• Product Code: OYC
• UDI-Device Identifier: 00643169933163
• UDI-Public: (01)00643169933163
• 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): 02/03/2020

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-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A6723LNAPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/03/2020
• 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: 73 YR
• Patient Weight: 220