MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7821LNA GST4C REPLACEMENT; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7821LNA

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced device unable to charge, led anomaly, change sensor/bad sensor.The customer reported no adverse event.The event involved product(s) mmt-7821lna, mmt-7020a.Customer received a change sensor alert.Customer is unable to run atransmitter test or test passed.Customer was advised to try anothersensor.Transmitter is not active/connected with app.Led light ontransmitterdid not blink as expected and transmitter was fully charged.No harm requiring medical intervention was reported.Mmt-7821lna was requested and customer response was the device will be returned.No product return is required for mmt-7020a.

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Received and placed unit under microscope and found contamination / corrosion damage at connector pins.Unable to perform functional test, verify battery or led anomaly due to contamination / corrosion damage at the connector pins.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: XMTR MMT-7821LNA GST4C REPLACEMENT
• 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: lusine boyadzhyan ; 18000 devonshire st.; northridge, CA 91325
• MDR Report Key: 19059077
• MDR Text Key: 339584251
• Report Number: 2032227-2024-151861
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2023
• Device Model Number: MMT-7821LNA
• Device Catalogue Number: MMT-7821LNA
• Device Lot Number: 1107665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 104 KG