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

Model Number MMT-318

Device Problems Fluid/Blood Leak (1250); Sticking (1597)

Patient Problem Hyperglycemia (1905)

Event Date 11/15/2013

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.See manufacturer report number 2032227-2013-05920.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 initially called for assistance with priming.The customer stated she changed the infusion set but was stuck in the fill tubing step.During the call, she reported that she was admitted into the hospital on (b)(6) 2013 due to high blood glucose and was still in the hospital.Customer's blood glucose value was over 500 mg/dl.The customer reverted to manual injections.She was about to be discharged and was trying to reconnect the insulin pump to make sure it was functioning.Blood glucose value was 225 mg/dl.Customer stated that insulin was squirting out of the tubing during manual prime but no gap seen the piston and reservoir stopper.The customer was unsure if the drive support cap was protruded or loose.The insulin pump 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: 5480329
• MDR Text Key: 39673286
• Report Number: 2032227-2016-04014
• 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: 11/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• 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: UNK318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2013
• 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): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 89