MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-399T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Customer reported via phone call that they were experiencing high blood glucose level.Blood glucose level at the time of the incident was 475 mg/dl, 550 m g/dl, 560 mg/dl, below 400 mg/dl.Customer experienced symptoms such as dizziness.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer did not allege insulin pump was under delivering.Customer was not using auto mode.Troubleshooting was performed.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM QUICK SET MMT-399T
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9979373
• Report Number: 2032227-2020-106548
• Device Sequence Number: 2089478
• Product Code: FPA
• UDI-Device Identifier: 05705244020467
• UDI-Public: (01)05705244020467(17)220701(10)5284942
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Model Number: MMT-399T
• Device Catalogue Number: MMT-399T
• Device Lot Number: 5284942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Weight: 243