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 Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2024

Event Type  malfunction  

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.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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported to medtronic minimed that the customer experienced motor error alarm, loose drive support cap.The customer reported no adverse event.The event involved product(s) mmt-754wws.Troubleshooting was performed.The customer will discontinue using the device and was advised to revert to the backup plan as per healthcare professional instructions.No harm requiring medical intervention was reported.Mmt-754wws was requested and customer response was the device will be returned.

• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 19199762
• MDR Text Key: 341359324
• Report Number: 2032227-2024-160459
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000084394
• UDI-Public: (01)000000763000084394
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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: B7754WWSJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 20 YR