MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 03/13/2024

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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 reported hyperglycemia ,infection, itching, rash, no consequences or impact to patient treated with emergency rescue.The event involved product(s) mmt-397a, mmt-723nal, mmt-397a, mmt-397a.Troubleshooting was partially performed and customer declined to troubleshoot.Customer has not been using the insulin pump system within 48hrs of reported high bg event.No further patient complications were reported.No product return is required for mmt-397a.No product return is required for mmt-723nal.No product return is required for mmt-397a.No product return is required for mmt-397a.

Event Description

Downgrading the case to non-reportable as the initial report was submitted in error.As per the case notes, the insulin pump was not used within 48 hours of the reported event and also the reason was that the customer had no sets (reservoir or infusion sets) to use.There was no issue with the insulin pump.

Manufacturer Narrative

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.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 18993424
• MDR Text Key: 338885986
• Report Number: 2032227-2024-148010
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 0000006139947439
• UDI-Public: (01)0000006139947439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: A3723NALJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 07/27/2010
• 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
• Treatment: FRN-MMT-UNK-RSVR, UNOMED INF SET.
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 87 KG