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	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected 1 random opened/used sensor and performed visual inspection and found contact pad to be damaged (wrinkled).Unable to confirm customer received sensor in said condition due to customer returned opened/used.(b)(4).
Event or Problem Description
The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm.Insulin delivery was suspended due to sensor values.The customer¿s blood glucose was 157 mg/dl and the sensor glucose was 46 mg/dl at the time of the incident.The insulin pump received sensor updating and change sensor.The sensor will be returned for 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: 9050674
• Report Number: 2032227-2019-62473
• Device Sequence Number: 14075417
• Product Code: OZP
• UDI-Device Identifier: 00763000140779
• UDI-Public: (01)00763000140779(10)HG2RUTDH05
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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 Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: HG2RUTDH05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 120