MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7020B ENLITE3 US; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020B
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	05/20/2018
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer's mother reported via phone call that they experienced low blood glucose level as well as high blood glucose level.The customer's low blood glucose level was 45 mg/dl.The customer's high blood glucose level was 406 mg/dl, 400 mg/dl and.506 mg/dl.The customer was treated by the juice for the low blood glucose level and by manual injections for high blood glucose level.Other relevant blood glucose level of the customer was 116 mg/dl.The customer declined to troubleshooting for blood glucose.The insulin pump will not be returned for the analysis and sensor will be returned for the analysis.

• Brand Name: SENSOR MMT-7020B ENLITE3 US
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7632916
• Report Number: 3004209178-2018-84559
• Device Sequence Number: 1788411
• Product Code: OZP
• UDI-Device Identifier: 00763000017569
• UDI-Public: (01)00763000017569(17)190312(10)HG2DN0DH01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2018

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: 03/12/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: HG2DN0DH01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/25/2018
• 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: Other
• Patient Age: 8 YR
• Patient Weight: 92