MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number	MMT-332A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hyperglycemia (1905); Malaise (2359); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported to medtronic minimed that the customer experienced hyperglycemia and diabetic ketoacidosis.The customer also reported a pump error 43.The customer experienced leak of reservoir.The blood glucose value at the time of the event was 687 mg/dl.The customer experienced symptoms of feeling sick/unwell during the event.The customer experienced hyperglycemia and diabetic ketoacidosis, had an emergency room visit, and was hospitalized and treated with intravenous insulin infusion.The event involved product(s) mmt-1884, mmt-332a, mmt-242a, and 78893-01.Troubleshooting was performed.The customer was using the auto mode/smart guard feature at the time of the event.The customer was using the insulin pump system within 48 hours of the reported event.No further patient complications were reported.The customer will discontinue use of the insulin pump.Mmt-1884 was requested, and the customer response was that the device will be returned.No product return is required for mmt-332a.No product return is required for mmt-242a.No product return is required for 78893-01.

• Brand Name: RESERVOIR 3ML MMT-332A
• Common Device Name: PUMP, INFUSION
• 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: goutham pendyala ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 24738696
• Report Number: 2032227-2026-151521
• Device Sequence Number: 9781669
• Product Code: FRN
• UDI-Device Identifier: 002076300027335801
• UDI-Public: (01)002076300027335801(17)280705(10)HG8XDR0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG8XDR0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 07/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332A-RSVR, UNOMED INF SET; QBJ-78893-01-SNSR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 88 KG