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

Model Number MMT-325

Device Problems Air Leak (1008); Bent (1059); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 01/25/2014

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 she has been experiencing high blood glucose for 4 days.Blood glucose value was 494 mg/dl.She experienced vomiting and dry mouth.She had treated with manual injections.During troubleshooting; the customer found a small and a larger air bubble in the infusion set's tubing and small bubbles in the reservoir.No insulin leaks noted.She removed the infusion set and found blood in the cannula and it was bent.The insulin pump was not rewound with a reservoir in place and insulin was not stored at room temperature but it was left out for 30 min to bring to room temperature.The insulin pump passed the high pressure test.She was advised to change the entire set, reservoir and insulin.When the customer primed the new tubing, insulin started squirting out.No compromised force sensor alarms were found in the alarm history or other issues with the insulin pump were noted.The customer changed the infusion set and reservoir and was able to prime.

• Brand Name: SOF SET MIRCO
• 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: 5483639
• MDR Text Key: 39782260
• Report Number: 2032227-2016-04018
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K001827
• 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: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-325
• Device Catalogue Number: MMT-325
• Device Lot Number: 50721558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2014
• 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: 73 YR
• Patient Weight: 61