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

Model Number MMT-7811NA

Device Problems Communication or Transmission Problem (2896); Moisture or Humidity Problem (2986)

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

Event Date 04/18/2021

Event Type  malfunction  

Event Description

Medtronic received information that exposed to moisture, no communication (unresolved) occurred.There was no adverse impact or consequence reported as a result of this event.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Unit received with contamination at the connector pins.Unable to perform functional test due to contamination damage.

• 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: 13772628
• MDR Text Key: 291633813
• Report Number: 2032227-2022-139646
• 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: 03/15/2022

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 Model Number: MMT-7811NA
• Device Catalogue Number: MMT-7811NA
• Device Lot Number: A000769307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 04/18/2021
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: 29 YR