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 Problem Renal Failure (2041)

Event Date 03/16/2022

Event Type  Death  

Event Description

It was reported that the customer had passed away on (b)(6) 2022 at hospice.The cause of death was renal failure.The customer blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The customer was using sensor.The insulin pump was returned for the analysis.The case was reported on the basis of failure analysis.

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.The pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat at 0.0874 inches.The stop (idle) current and run current measurement tests are within specification.The pump also passed self test, off no power alarm test and a21 error test.The pump had intermittent button response on the esc, act, up arrow and down arrow buttons due to flattened dome switches (no crease).No button error alarm noted.The following were noted during visual inspection: cracked battery tube threads, cracked case at the reservoir tube window corner, cracked reservoir tube window, cracked reservoir tube lip and missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.Please see below when reviewing the history download.The pump did not have a battery installed when received.The download history file lists data from 08/10/2021 to 02/01/2022.There was no data listed on march 2022.The pump passed the functional testing.The pump had intermittent button response due to flattened dome switches (no crease) was confirmed.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Information has been corrected which was not correct in the initial report.The information has been provided in section b5 with this report.

Event Description

It was reported that the customer had passed away on (b)(6), 2022 at hospice.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 14082350
• MDR Text Key: 289053335
• Report Number: 2032227-2022-178429
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169513099
• UDI-Public: (01)000000643169513099
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A1523RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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 Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 73 KG