MAUDE Adverse Event Report: MEDTRONIC MINIMED 630G INSULIN PUMP

Catalog Number MMT-1755KMK

Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Nausea (1970); Sweating (2444); Palpitations (2467); Missed Dose (2561)

Event Date 12/31/2016

Event Type  Injury  

Event Description

A medtronic 630g insulin pump failed to deliver bolus to my wife during the night of (b)(6) 2016 and she awoke at 6:00 am. On the morning of (b)(6), with heart racing, sweating, and nausea. We tested her blood glucose to be 581 mg/dl. I gave my wife manual bolus with a syringe. I removed the reservoir from the pump and disconnected the delivery tube at the infusion site. I noticed the amount of insulin in the reservoir to be approx 30 units. I navigated the pump's software menu to the reservoir level which indicated 76 units. The infusion catheter device and reservoir had been changed prior to dinner on (b)(6) 2016. At this time the reservoir had been filled to 120 units of insulin (as performed 8 previous times). I called medtronic's help line at (b)(4). In explained the reservoir discrepancy to the assistant on the phone. I stated that two instances of 5 unit bolus treatments had been performed and in the 11 hours since the reservoir and infusion set had been changed 5. 5 units of basil was delivered. I told the assistant on the phone that the amount of insulin delivered should have been 15. 5 units yet, the reservoir indication of 30 remaining units is based on the reservoir's graduated scale. I also mentioned to the assistant that the pump's software was indicating remaining insulin of 76 units. The assistant helped me perform a series of tests on the pump over the phone. In one test she had me rewind the pumps actuator, reload the used reservoir (30 units), and advance the pump's actuator to the reservoir's piston. When the pump completed the change reservoir steps its software alarmed and showed 11 units remaining. An indication to change reservoir was annunciated. In summary, the pump's software reported 76 units prior to my removing the reservoir. I removed the reservoir and the level indicated 30 units on its graduated scale. Afer rewinding the pump's actuator, operating satisfactory. She suggested we continue using the pump with a new infusion set in a different on her body. I believe a more serious problem with the pump exists rather than an infusion set placement problem. We have discontinued using the insulin pump.

• Brand Name: MINIMED 630G
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6237087
• MDR Text Key: 64483016
• Report Number: MW5067141
• Device Sequence Number: 0
• Product Code: OZO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: MMT-1755KMK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/06/2017 Patient Sequence Number: 1

Treatment

HUMALOG; LANTUS