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

0 Patients were 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

• Device Expiration Date: 04/01/2019
• Device Model Number: MMT-7020
• Device Lot Number: D018
• 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