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

Model Number PARADIGM

Device Problems Device Alarm System (1012); Self-Activation or Keying (1557)

Patient Problem Death (1802)

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).

• Brand Name: MINIMED
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8869110
• MDR Text Key: 153658525
• Report Number: MW5088848
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PARADIGM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 73