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

Model Number MMT-754WWS

Device Problems Insufficient Flow or Under Infusion (2182); Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/09/2022

Event Type  Injury  

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 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 the customer reported that the pump was under delivery.It is reported changes on her drive support cap.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will continue using the device and the pump will not be returned for analysis.

Manufacturer Narrative

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.The information that provided with the initial report was incorrect.The correct information has been included with this report in b5 section.Information related device problem fda code has been updated in h6 section.

Event Description

The drive support cap was loose.The insulin pump will be returned for analysis.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.¿select patient information cannot be provided due to regional privacy regulations." s/w 3.1e the customer was hospitalized for alleged high bgs/dka, possible under delivery anomaly and located at the drive support cap on (b)(6) 2022.The pump passed the functional test, including the displacement test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat at 0.0875 inches.Possible under delivery anomaly not confirmed.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.Drive support disk was inspected and no anomaly was noted.The following were noted during visual inspection: minor scratched display window, and cracked battery tube threads.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.The pump did not have a battery installed when received.No damage noted on the original battery cap.Please see below when reviewing the history download.There is no data available due to the pump was stored for an extended period without a battery.There was no data available for the history review 1 week prior to the event date (b)(6) 2022 in the formatted history file.The pump passed the functional testing.Unable to confirm alleged high bgs/dka.Possible under delivery anomaly not confirmed.Loose drive support cap not confirmed however, other cosmetic damage was noted.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.The information related to additional manufacturer narrative has been updated and provided in h10 section of this report.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS
• 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: 16058644
• MDR Text Key: 306243787
• Report Number: 2032227-2022-389466
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2023

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-754WWS
• Device Catalogue Number: MMT-754WWS
• Device Lot Number: B8754WWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/23/2023; 03/24/2023
• Supplement Dates FDA Received: 01/25/2023; 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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