MAUDE Adverse Event Report: MEDTRONIC MINIMED ASSEMBLY, SENSOR, ENLITE D, STERILE; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number 7006027-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The subject for clinical study reported via phone call that they had an adverse event with a diagnosis of paresthesia of the skin caused by the sensor.The subject had a light burning on right abdomen sensor area after lying on stomach during physical therapy.Customer¿s blood glucose level was unknown at the time of incident.The sensor will not be returned for analysis.

• Brand Name: ASSEMBLY, SENSOR, ENLITE D, STERILE
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 9217432
• MDR Text Key: 163114576
• Report Number: 2032227-2019-107535
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7006027-001
• Device Catalogue Number: 7006027-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other