MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397T

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

Patient Problem Hyperglycemia (1905)

Event Date 10/29/2015

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.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 Description

Customer reported via phone call that they had a high blood glucose level of 600 mg/dl.Customer treated the elevated blood glucose with a manual injection of insulin.Customer was able to troubleshoot during the call.Customer reported that the infusion set cannula was not bent.Customer reported discoloration of the infusion set tubing.The product is expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-397T
• 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: 7213540
• MDR Text Key: 98017990
• Report Number: 2032227-2018-00933
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20643169174324
• UDI-Public: (01)20643169174324(017)20160901
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/23/2018

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: 09/01/2016
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Device Lot Number: 002914185T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 01/23/2018
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR