MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-864T
Medical Device Problem Codes	Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/11/2020
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
It was reported that the customer experienced hyperglycemia.The customer switched to a different infusion set.The customer stated that they rode the exercise bike for 20 minutes and the blood glucose went from 10 mmol/l to 23 mmol/l.The customer stated that they did not know if the infusion set was working.The customer reported that they bolused with the insulin pump.It was reported that the customer had always used quickset and was developing an allergy probably to the plastic cannula.The customer declined troubleshooting for high blood glucose.The insulin pump will not be returned for analysis.

• Brand Name: INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 10035049
• Report Number: 2032227-2020-114863
• Device Sequence Number: 11497350
• Product Code: FPA
• UDI-Device Identifier: 05705244020733
• UDI-Public: (01)05705244020733(17)220601(10)5285099
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

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 Model Number: MMT-864T
• Device Catalogue Number: MMT-864T
• Device Lot Number: 5285099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2020
• Initial Report FDA Received Date: 05/07/2020
• 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