MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754DES

Device Problems No Display/Image (1183); Battery Problem (2885); Failure of Device to Self-Test (2937)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Urinary Tract Infection (2120)

Event Date 10/15/2020

Event Type  malfunction  

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.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.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

Information received by medtronic indicated that insulin pump had blank display.Customer reported that felt symptoms such as head pain, dry mouth, and urinary infection.Customer was oriented to run a high presser test, without success, second attempt to run high presser test failed.The insulin pump was not dropped or bumped and did not present signs of physical damages.The insulin pump was not exposed to high magnetic field and support drive cap was normal.No harm requiring medical intervention was reported.The customer was assisted with troubleshooting.Customer had changed the infusion set system and issue was resolved.Customer inform that insulin pump was presenting intercurrences with the low battery alert.Customer did not press much buttons and insulin pump was on beep mode.Alarms were cleared instantly and back light was used only at night.Customer informs that in the last battery change insulin pump presented blank display and taken some time to return to work, and due to that, customer changed the batteries for 3 times.The device will be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.0873 inches.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using carelink.Device powered up properly after the test battery was installed.Device was monitored for 2 days.No blank display, charge/battery anomaly, unexpected low battery alarm or unexpected off no power alarm noted.Device had cracked battery tube threads, scratched reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES
• 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
• MDR Report Key: 10725114
• MDR Text Key: 212728187
• Report Number: 2032227-2020-195512
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000084356
• UDI-Public: (01)000000763000084356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754DES
• Device Catalogue Number: MMT-754DES
• Device Lot Number: A9754DESJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1