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

Model Number MMT-397T

Device Problems Bent (1059); Failure to Deliver (2338)

Patient Problem Hyperglycemia (1905)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6). 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

The customer reported via phone call on (b)(6), that the insulin pump was not delivering insulin. The customer¿s blood glucose level was unknown at the time of the incident. Customer did note they have been receiving high blood glucose frequently and has back up plans ready. Customer notes he has troubleshoot himself and requests a new infusion set. During troubleshooting, customer was advised to disconnect at the quick release and the entire infusion set. An l-shaped bent cannula was discovered upon removal. The customer was advised a replacement infusion set will be sent out. The infusion set is not expected to be returned for analysis.

• 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: 6989119
• MDR Text Key: 90625421
• Report Number: 2032227-2017-62903
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/22/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/30/2017 Patient Sequence Number: 1