MAUDE Adverse Event Report: MEDTRONIC MINIMED 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); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected one opened/used sensor and performed continuity resistance test and sensor failed test.Found cannula bent unable to confirm customer received sensor in said condition due to customer returned opened/used.
Event or Problem Description
Information received by medtronic the user reported inaccurate sensor readings that triggered a threshold suspend.The customer¿s blood glucose was 130 mg/dl and sensor glucose was 80 mg/dl at the time of the event, the difference is outside the acceptable range.Suspend on low limit in sensor settings was at 65 mg/dl.No harm requiring medical intervention was reported.The sensor will be returned for analysis.
Additional Manufacturer Narrative
The initial report was submitted with an incorrect date.The correct date is 28-sep-2018.

• Brand Name: SENSOR MMT-7020A ENLITE3 5PK US
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9688299
• Report Number: 2032227-2020-101041
• Device Sequence Number: 2401836
• Product Code: OZP
• UDI-Device Identifier: 20643169704057
• UDI-Public: (01)20643169704057(17)190123(10)A238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/11/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/23/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: A238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 152