MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK PERSONAL MMT-7333; SENSOR, GLUCOSE, INVASIVE

Model Number	MMT-7333
Medical Device Problem Code	Unauthorized Access to Computer System (3025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to minimed that the nurse uploaded pump data of another patient in the carelink.The customer reported no adverse event.The event involved product(s) mmt-7333.Troubleshooting was performed.Customer confirmed cybersecurity and hacking allegation.Instructions were provided to resolve the issue, no escalation required.No harm requiring medical intervention was reported.Product return is not applicable for non-physical device mmt-7333.
Additional Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.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.

• Brand Name: CARELINK PERSONAL MMT-7333
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: keya patel ; 18000 devonshire st.; northridge, CA 91325
• MDR Report Key: 50673424
• Report Number: 2032227-2026-235774
• Device Sequence Number: 10234882
• Product Code: MDS
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-7333
• Device Catalogue Number: MMT-7333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/08/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown