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 Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	11/18/2018
Type of Reportable Event	Malfunction
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.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 reported via phone call that the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 101 mg/dl and the sensor glucose was 92 mg/dl.Insulin delivery was suspended due to sensor values.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable rang.The sensor will be returned for analysis.
Additional Manufacturer Narrative
Inspected one opened and sensor and performed continuity resistance test.Sensor passed per specifications.Sensor initialization test was performed using a new lab transmitter with a paradigm pump.Connected sensor to the transmitter and placed it in 100 bbs solution and confirmed communication icon was displayed and that the transmitter was flashing while connected to the sensor.The sensor functioned properly.Cannot perform buffered test solution, the sensor is beyond its expiration date.Unable to confirm adhesive anomaly on opened/used sensor.(b)(4).

• 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: 8113405
• Report Number: 2032227-2018-68135
• Device Sequence Number: 2165846
• Product Code: OZP
• UDI-Device Identifier: 20763000017556
• UDI-Public: (01)20763000017556(17)190312(10)HG2DN00
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/15/2019

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: 03/12/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: HG2DN00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 11/18/2018
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 260