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

Model Number MMT-318

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 12/25/2013

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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 they experienced high blood glucose.The customer reported that they found air bubbles in the reservoir and tubing.The customer's blood glucose was 600 mg/dl at the time of incident.The customer stated that they treated the high blood glucose with manual injection.The customer stated that they did not rewind the insulin pump with a reservoir in place.The customer stated that the insulin was not stored at room temperature.The infusion set will not be 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: 5657413
• MDR Text Key: 45280900
• Report Number: 2032227-2016-10980
• 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: 12/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-318
• Device Catalogue Number: MMT-318
• Device Lot Number: 20226254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Weight: 88