MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-722LNAS

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

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The unit did not have a battery installed when received.Unit passed the displacement test, rewind, basic occlusion test, prime/a33 test, excessive no delivery test, self test, insulin pump error error test and the dat test at 0.0876 inches.All operating currents are within specification.Off no power alarm functions properly.Unit alarmed motor error during occlusion test due to faulty fsr (gold).The motor was tested outside of the unit and passed.Unit uploaded properly using carelink.Unit had cracked reservoir tube and a partially broken off reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: there is no data available due to the unit did not have a battery installed when received.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 Description

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2020.The cause of death was bleeding in the brain.The caller stated that the customer had bleeding in the brain 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 admission and the customer was treated with manual injections.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.This report is being created only for the failure analysis results.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 11153056
• MDR Text Key: 227766955
• Report Number: 2032227-2021-102908
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 0000006139944095
• UDI-Public: (01)0000006139944095
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722LNAS
• Device Catalogue Number: MMT-722LNAS
• Device Lot Number: A000114695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2011
• 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
• Patient Age: 73 YR
• Patient Weight: 103