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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC 630G INSULIN PUMP

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MEDTRONIC MINIMED MEDTRONIC 630G INSULIN PUMP Back to Search Results
Model Number 630G
Device Problems Pump (925); Output Problem (3005); Reset Problem (3019)
Patient Problems Death (1802); Hypoglycemia (1912); Overdose (1988)
Event Date 01/23/2018
Event Type  Death  
Event Description

I have attempted to report this twice this morning and have failed to complete the document. So i will make this short. My wife died because of an overdose of insulin. It was caused because the medtronic 630g insulin pump had reset its settings from "grams" to "units. " this caused an incorrect bolus to be given. I have downloads and documents i have sent to my company's life insurance administrator for an accidental death policy. I can send them to you, too. I have downloads from the website to monitor her pump including a. Csv file. The death certificate lists a different cause of death. But the cause of death they used was the one that occurred after they put her on comfort measures. It shows contributing factors of hypoglycemia. I tried to see if the pump would reset again. But it has not done it. But when the problem occurred it was very dry and static electricity was easily generated. I am a functional safety mgr for (b)(4), formerly (b)(4). So i understand the testing and documentation that is required to put a safety product onto production. (b)(6).

 
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Brand NameMEDTRONIC 630G INSULIN PUMP
Type of DeviceMEDTRONIC 630G INSULIN PUMP
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key7769683
MDR Text Key116709952
Report NumberMW5079016
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
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 08/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number630G
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/08/2018 Patient Sequence Number: 1
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