MAUDE Adverse Event Report: MEDTRONIC RESERVOIR

Model Number MMT-332A

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

I am an insulin dependent diabetic and use a medtronic insulin pump.This pump uses their reservoir mmt-3321.I reported them in february of this year that bubbles were forming in the reservoir which migrated down-line into the tubing that resulted in insufficient insulin dosing.Air was administered instead of insulin.They requested i save samples that illustrated this issue.They sent me a mailer and i submitted four reservoirs that exhibited the formation of the described air bubbles forming especially around the o-rings at the junction with the insulin in the reservoir.I never heard anything back from medtronic.This fall i called them since i was still seeing the air bubbles forming in the reservoir and inquired if there was anything to report, especially in regards to my submitted samples.I was told that there was nothing to report since i had not requested a report upon submission of the samples.I did not know such request was required.This week, specifically (b)(6) 2014 at 6:00 am, i experienced a fasting elevated blood sugar of 304.I looked at the tubing feeding insulin to the infusion set and observed numerous air bubbles, and the reservoir had several air bubbles as well.I kept this reservoir and tubing for illustration purposes.I believe the o-rings do not sufficiently keep air out of the reservoir and are defective or inadequate.Air in th reservoir migrating into the tubing and eventually to the infusion set will result in inadequate insulin dosing and higher than acceptable blood sugar levels-an unhealthy situation for diabetics.Results not reported to submitter.

• Brand Name: RESERVOIR
• Type of Device: RESERVOIR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4297214
• MDR Text Key: 16307671
• Report Number: MW5039370
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2017
• Device Model Number: MMT-332A
• Device Lot Number: HG07NFT
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 77