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

Model Number	MMT-723RNAH
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
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
The customer reported via phone call that they were hospitalized due to diabetic ketoacidosis and high blood glucose on (b)(6) 2018 with blood glucose of 1200 mg/dl.Customer's other blood glucose level was 350 mg/dl.The customer did not provide details regarding symptoms of their high blood glucose episodes.Customer was treated with emergency medical service, intensive care unit and intravenous insulin drip.Customer stated that the insulin pump had received no delivery alarms.Customer continue with troubleshoot for no delivery.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
• 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: 8305508
• Report Number: 3004209178-2019-52002
• Device Sequence Number: 62155
• Product Code: OYC
• UDI-Device Identifier: 00643169476578
• UDI-Public: (01)00643169476578
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A0723RNAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial 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: 52 YR
• Patient Weight: 132