MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522RNAS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit had cracked case at the reservoir tube window corners, cracked reservoir tube window, cracked belt clip slot, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.The pump passed the displacement test and p-cap locks properly into the reservoir compartment.Cosmetic damage was confirmed at cracked case and reservoir tube window corners.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 that the pump has a crack.The customer reported no adverse event.The event involved product(s) mmt-522rnas.Troubleshooting was performed and found that pump has a damage at reservoir window, between window and esc button.No harm requiring medical intervention was reported.Customer will discontinue to use the pump.Product mmt-522rnas was requested and pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: lusine boyadzhyan ; 18000 devonshire st.; northridge, CA 91325
• MDR Report Key: 23678380
• Report Number: 2032227-2025-308923
• Device Sequence Number: 8901497
• Product Code: OYC
• UDI-Device Identifier: 00613994408907
• UDI-Public: (01)00613994408907
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980022
• 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): 12/01/2025

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-522RNAS
• Device Catalogue Number: MMT-522RNAS
• Device Lot Number: A000114836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2008
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG