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); Unexpected Therapeutic Results (1631); Calibration Problem (2890); Material Twisted/Bent (2981); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected 1 opened/used sensor and performed visual inspection and found contact pad to be damaged (wrinkled).Unable to confirm customer received sensor in said condition due to customer returned opened/used.Also found cannula bent.Unable to confirm customer received sensor in said condition due to customer returned sensor opened/used.
Event or Problem Description
Customer reported via phone call that the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 237 mg/dl and the sensor glucose was 46 mg/dl.The customer was assisted with troubleshooting.Insulin delivery was suspended due to sensor values.Customer states the sensor value that triggered the suspend on low or suspend before low event was 46 mg/dl.Suspend on low limit in sensor settings was 70.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
The initial report was submitted with the wrong aware date.The correct aware date is 11-aug-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: 8777550
• Report Number: 2032227-2019-27893
• Device Sequence Number: 1822762
• Product Code: OZP
• UDI-Device Identifier: 20643169704057
• UDI-Public: (01)20643169704057(17)190420(10)D208
• 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): 07/15/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/20/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: D208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR