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

Model Number	MMT-7811NA
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Customer reported via phone call that customer had doctor visit due to skin burn, ulceration and discharge on 6 or 8 weeks ago.Customer was treated with antibiotics and dressing changes to the infection itself.Customer was wearing transmitter or sensor at time of hospitalization.Customer also experienced high blood glucose of 307mg/dl and declined troubleshoot for high blood glucose.Products will not be return for analysis.
Additional Manufacturer Narrative
The event was reported in error.

• Brand Name: XMTR MMT-7811NA GST3C LOCKOUT
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7555996
• Report Number: 2032227-2018-04142
• Device Sequence Number: 11391020
• Product Code: MDS
• UDI-Device Identifier: 00643169955691
• UDI-Public: (01)00643169955691(017)20180217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/17/2018
• Device Model Number: MMT-7811NA
• Device Catalogue Number: MMT-7811NA
• Device Lot Number: A000396921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 118