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 Code	Calibration Problem (2890)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Inspected 1 opened/used sensor and performed continuity resistance test.Sensor passed per specification.Also, performed bicarbonate buffer test.Sensor passed per specifications with accurate readings.Also, performed visual inspection and checked insertion needle for burrs/hooks and dull needle tip defects and none was found.Insertion needle passed per specifications.
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 73 mg/dl and sensor glucose was 43 mg/dl at the time of incident when it triggered threshold suspend.The customer's blood glucose was 83 mg/dl at the time of call.The sensor was returned for analysis.

• 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: 7815374
• Report Number: 2032227-2018-17494
• Device Sequence Number: 13965569
• Product Code: OZP
• UDI-Device Identifier: 20763000017556
• UDI-Public: (01)20763000017556(017)20190122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/24/2018

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: 01/22/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: HG29UDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 176