MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-905T MIO 2PK 13MM23N; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-905T

Device Problems Bent (1059); Material Discolored (1170)

Patient Problem Hyperglycemia (1905)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 2017.Subsequently, medtronic diabetes conducted a two year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.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 Description

Customer reported via phone call that they had a high blood glucose level of 27 mmol/l.Customer treated the elevated blood glucose level with a manual injection of insulin.The customer was able to troubleshoot during the call.Customer disconnected at the quick release and attempted to perform a fixed prime.Customer reported that insulin did exit the infusion set tubing.Customer reported white discoloration of the infusion set tubing.The customer reported that the infusion set cannula was bent.No product is expected to be returned.

• Brand Name: INFST MMT-905T MIO 2PK 13MM23N
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7251943
• MDR Text Key: 99358939
• Report Number: 2032227-2018-01346
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20643169668359
• UDI-Public: (01)20643169668359(017)20190201
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Model Number: MMT-905T
• Device Catalogue Number: MMT-905T
• Device Lot Number: 5136899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 02/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other