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); Unexpected Therapeutic Results (1631); Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
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.The device has been returned, but not yet evaluated.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 106 mg/dl and sensor glucose value was 45 mg/dl.Insulin delivery was not suspended due to sensor glucose and blood glucose.Sensor glucose value that triggered suspend event was 45 mg/dl.Suspend on low limit in sensor settings was 80 mg/dl.Blood glucose value associated with the triggered suspend event was 160 mg/dl.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Customer did not receive a sensor updating alert.Customer did receive a calibration not accepted alert.Customer did receive a change sensor alert.The sensor will be returned for analysis.
Additional Manufacturer Narrative
Inspected 1 opened or used sensor and performed continuity resistance test.Sensor failed per specifications.Also found cannula bent.Unable to confirm customer received sensor in said condition due to customer returned opened or used.

• 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: 9096484
• Report Number: 2032227-2019-66107
• Device Sequence Number: 2568443
• Product Code: OZP
• UDI-Device Identifier: 00763000140779
• UDI-Public: (01)00763000140779(17)200421(10)HG3C34CH08
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/19/2020

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: 04/21/2020
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: HG3C34CH08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 83