MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN LINK 3 US; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7911NA

Device Problem Communication or Transmission Problem (2896)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/06/2021

Event Type  malfunction  

Event Description

Medtronic indicated that no communication (unresolved) occurred.Customer reported loss of communication between the insulin pump and transmitter.The customer reported that they had low blood glucose.Customer did not report a loss of communication event that has been resolved and/or sensor has been removed.Customer stated at the time of event was 34 mg/dl.The customer did not experience any symptoms such as a result of low blood glucose.The customer declined troubleshooting for low blood glucose level.Customer was unconscious as he fell down on transmitter.It was unknown that if the insulin pump was in auto mode at the time of the incident.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.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.

• Brand Name: GUARDIAN LINK 3 US
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13881941
• MDR Text Key: 295815556
• Report Number: 2032227-2022-170310
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2021
• Device Model Number: MMT-7911NA
• Device Catalogue Number: MMT-7911NA
• Device Lot Number: 999687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 03/24/2022
• Date Device Manufactured: 11/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 99 KG