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
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The customer reported via phone call the sensor had triggered threshold suspend event and it was shutting off everything.The customer¿s blood glucose was 180 mg/dl and the sensor glucose was 40 mg/dl.Insulin delivery was suspended due to sensor values.Sensor value that triggered the suspend event was below 40 mg/dl.Suspend on low limit in sensor settings was 70 mg/dl.It was also reported that the customer experienced hypoglycemia and blood glucose level was 40 mg/dl at the of suspended.The sensor will not returned for analysis.
Additional Manufacturer Narrative
Additional information about blood glucose has been received which was not included with the initial report.The information has been provided with this report.(b)(4).
Event or Problem Description
It was reported that the customer's blood glucose was 180 mg/dl.

• 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: 9183411
• Report Number: 2032227-2019-102424
• Device Sequence Number: 14107275
• Product Code: OZP
• UDI-Device Identifier: 00763000140779
• UDI-Public: (01)00763000140779(17)200605(10)HG3ER14H07
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 10/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/05/2020
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: HG3ER14H07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/12/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: 46 YR
• Patient Weight: 138