MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7811NA

Device Problems Calibration Problem (2890); Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Unit failed to communicate and sync during rf association, problem was isolated to electronic assembly.

Event Description

Medtronic received information that unexpected re-initialization, change sensor/bad sensor, no communication (unresolved) occurred.There was no adverse impact or consequence reported as a result of this event.

• Brand Name: XMTR MMT-7811NA GST3C LOCKOUT
• 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: 13737444
• MDR Text Key: 297040627
• Report Number: 2032227-2022-128915
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7811NA
• Device Catalogue Number: MMT-7811NA
• Device Lot Number: 1004278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Weight: 195