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

Model Number	MMT-7821LNA
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to medtronic minimed that the customer experienced no com other device to mobile, calibration error/ calibration not accepted.The customer reported no adverse event.The event involved product(s) css7201, mmt-7821lna, mmt-7020a.The troubleshooting was partially performed customer received.Unable to complete troubleshooting or provide instructions, insufficient information to escalate.Customer reports receiving sensor alert.No harm requiring medical intervention was reported.No product return is required for css7201.No product return is required for mmt-7821lna.No product return is required for mmt-7020a.
Additional Manufacturer Narrative
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.Select patient information cannot be provided due to regional privacy regulations.This is 2 of 1 medwatch reports regarding this event.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
• Common Device Name: 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: 19211354
• Report Number: 2032227-2024-161260
• Device Sequence Number: 7383523
• Product Code: MDS
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/11/2023
• Device Model Number: MMT-7821LNA
• Device Catalogue Number: MMT-7821LNA
• Device Lot Number: 1085761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/30/2024
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female