MAUDE Adverse Event Report: MEDTRONIC MINIMED SOF SET ULTIMATE; FPA

Model Number MMT-317

Device Problems Air Leak (1008); Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 10/28/2013

Event Type  Injury  

Manufacturer Narrative

One opened/used infusion set was inspected and manual prime test was performed using a new lab reservoir along with an insulin pump.The infusion set failed per specifications due to being occluded at the tubing quick release connection septum side.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.

Event Description

The customer reported via phone call that the insulin pump alarmed no delivery.The customer had changed the infusion set three times but the alarm was recurring and her blood glucose was high at 548 mg/dl.Customer confirmed that the reservoir was not empty and the tubing did not have air.The customer disconnected and was able to perform fixed prime.She was advised there may be a site related issue.The customer removed the infusion set and stated the cannula was not bent.The infusion set was replaced and returned for analysis.

• Brand Name: SOF SET ULTIMATE
• Type of Device: FPA
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5480324
• MDR Text Key: 39673495
• Report Number: 2032227-2016-04010
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K001832
• 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: 10/28/2013

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 Model Number: MMT-317
• Device Catalogue Number: MMT-317
• Device Lot Number: 50669667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2013
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 52 YR
• Patient Weight: 97