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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED PUMP, INFUSION, INSULIN

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MEDTRONIC MINIMED MINIMED PUMP, INFUSION, INSULIN Back to Search Results
Model Number PARADIGM
Event Date 07/06/2019
Event Type  Death  
Event Description

The device suspended insulin delivery basaglor overnight, without user pressing any button. No alarms went off since it was in suspend mode. This led to estimated 9 hrs without insulin and her sugars went off the top of the reading of her glucose monitor by morning, leading to death later that day. Fda safety report id# (b)(4).

 
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Brand NameMINIMED
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key8869110
Report NumberMW5088848
Device Sequence Number1
Product CodeOYC
Report Source Voluntary
Reporter Occupation
Report Date 08/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberPARADIGM
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: 08/06/2019 Patient Sequence Number: 1
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