MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7020A ENLITE3 5PK US; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported via phone call to have experienced sensor glucose versus blood glucose differences with threshold suspend.Customer's sensor glucose was 89 and blood glucose was 161 mg/dl.Troubleshooting was performed and customer was advised on proper sensor usage and calibration techniques.Customer was advised that sensor would be replaced.

• Brand Name: SENSOR MMT-7020A ENLITE3 5PK 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: 8352320
• Report Number: 3004209178-2019-57281
• Device Sequence Number: 1682790
• Product Code: OZP
• UDI-Device Identifier: 20763000118864
• UDI-Public: (01)20763000118864(17)190504(10)HG2HRNG
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/19/2019

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: 05/04/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: HG2HRNG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 93