MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM 551 INSULIN PUMP

Model Number MINIMED RESERVOIRS

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

For the last month or more, i've noticed that medtronic minimed reservoirs become filled air bubbles during use.I'm not sure how long this has been occurring, but it came to my attention after i had trouble with extreme blood sugar highs.It seemed that the highs may have been related to the air bubbles traveling slowly through the infusion set and interrupting the constant insulin basal.I use minimed paradigm 551 insulin pump.The reservoir is (b)(4) 1.8 ml size.Currently using ref: (b)(4); lot: hg1nxb4.Not sure if the potential problem is with the pump or the reservoir.

• Brand Name: MINIMED PARADIGM 551 INSULIN PUMP
• Type of Device: MINIMED PARADIGM 551 INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6868322
• MDR Text Key: 86563827
• Report Number: MW5072148
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)200216(10)
• Combination Product (y/n): N
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/16/2020
• Device Model Number: MINIMED RESERVOIRS
• Device Catalogue Number: CE0459
• Device Lot Number: HG1NXB4
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 70