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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED 630G INSULIN PUMP

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MEDTRONIC MINIMED 630G INSULIN PUMP Back to Search Results
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.
 
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Brand NameMINIMED 630G
Type of DeviceINSULIN PUMP
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6237087
MDR Text Key64483016
Report NumberMW5067141
Device Sequence Number0
Product Code OZO
Reporter Country CodeUS
Number of Events Reported1
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 Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMMT-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
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