MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7020A ENLITE3 5PK US; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-7020B
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected 1 opened/used sensor and performed continuity resistance test.Sensor passed per specifications.Sensor initialization test was performed using a new lab transmitter with a 7xx/5xx paradigm pump.Connected sensor to the transmitter and placed it in 100 bts solution and confirmed communication icon was displayed and that the transmitter was flashing while connected to the sensor.The sensor functioned properly.
Event or Problem Description
The customer reported via phone call that they experienced inaccurate readings and triggered threshold suspend.The customer's blood glucose was 77 mg/dl and sensor glucose was 47 mg/dl at the time of incident when it triggered threshold suspend.The customer stated that they did not have a bent cannula on the sensor.The sensor will be returned for analysis.
Additional Manufacturer Narrative
The information was incorrect with the initial report.The correct information has been provided with this report.

• Brand Name: SENSOR MMT-7020A ENLITE3 5PK US
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7755373
• Report Number: 2032227-2018-09937
• Device Sequence Number: 1434617
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(017)20180519
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/01/2018

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: 05/19/2018
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: E197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2017
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 160