MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-975T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/29/2020
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.
Event or Problem Description
The customer reported via phone call that they were experiencing high blood glucose.Blood glucose level at the time of the incident was 441 mg/dl.Customer stated that insulin pump had leak at site and was not able to change the infusion set.Customer stated that they treated with insulin pump.Customer declined to troubleshoot for high blood glucose.The infusion set will be returned for analysis.

• Brand Name: INFST MM T-975T MIO 2PK 9MM 32IN CLEAR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 10383884
• Report Number: 2032227-2020-160178
• Device Sequence Number: 19379694
• Product Code: FPA
• UDI-Device Identifier: 05705244020580
• UDI-Public: (01)05705244020580(17)230201(10)5310503
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: 02/01/2023
• Device Model Number: MMT-975T
• Device Catalogue Number: MMT-975T
• Device Lot Number: 5310503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: 24 YR
• Patient Weight: 190