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

Model Number MMT-523RNAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Urinary Tract Infection (2120); Diabetic Ketoacidosis (2364)

Event Date 07/28/2019

Event Type  Death  

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 Description

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2019 due to urinary tract infection and diabetic ketoacidosis.The cause of death was diabetic ketoacidosis.The caller stated that the customer had urinary tract infection that may have led to the customer's passing.The customer¿s blood glucose was over 600 mg/dl at the time of death.The customer was wearing the insulin pump at the time of death.The customer was not using sensors.The caller stated the customer's high blood glucose was related to urinary tract infection, but the customer declined treatment for the infection and the high.The caller declined to return the insulin pump for analysis as the device was donated.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 11115307
• MDR Text Key: 225028701
• Report Number: 2032227-2021-100533
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169513099
• UDI-Public: (01)000000643169513099
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A1523RNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Date Device Manufactured: 09/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-326-RSVR UNOMED SET
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 110