MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN SENSOR (3); SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7020

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2018

Event Type  malfunction  

Event Description

I am currently own a medtronic minimed 670g resulting pump system that includes their guardian link continuous glucose monitoring system.I experienced two quality issues with the cgm system on this day.The first sensor insert's needle remover device did not unlock from the sensor properly, and in turn as i pulled the removal device, it pulled the entire sensor out of the area i inserted it.This of course rendered the sensor device useless.I inserted a 2nd new sensor device and it went fine until the sensor would not calibrate properly and i was instructed to remove it.Since late (b)(6) i have had a total of two boxes of 5 sensors per box that i have used.Out of those 10 sensors, 4-5 have been bad or had quality issues such as mentioned above.Where i am from those are not good statistics.

• Brand Name: GUARDIAN SENSOR (3)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 7502125
• MDR Text Key: 108095495
• Report Number: MW5077096
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2019
• Device Model Number: MMT-7020
• Device Lot Number: D018
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 152