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	Break (1069); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Blood Loss (2597)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inspected 1 opened/used partial sensor and performed visual inspection and found sensor cannula retracted inside sensor base and found broken cannula broken part is missing.See picture attachment file for details.Unable to confirm customer received sensor in said condition due to customer returned opened/used.Missing 1 insertion needle.
Event or Problem Description
Customer reported via phone call sensor anomaly.Customer¿s blood glucose level was unknown.Customer advised the sensor was missing an electrode.Customer was advised to return the sensor and that a replacement sensor would be sent out.Sensor will be return for analysis.
Additional Manufacturer Narrative
Inspected 1 opened/used partial sensor and performed visual inspection and found sensor cannula retracted inside sensor base and found broken cannula broken part is missing.See picture attachment file for details.Unable to confirm customer received sensor in said condition due to customer returned opened/used.Missing 1 insertion needle.
Additional Manufacturer Narrative
The information was not included in the initial report.The correct information has been provided with this report.
Additional Manufacturer Narrative
Inspected one opened and used partial sensor and performed visual inspection and found sensor cannula retracted inside sensor base and found broken cannula broken part is missing.See picture attachment file for details.Unable to confirm customer received sensor in said condition due to customer returned opened and used.Missing one insertion needle.

• 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: 7983963
• Report Number: 2032227-2018-45824
• Device Sequence Number: 11121367
• Product Code: OZP
• UDI-Device Identifier: 20643169704057
• UDI-Public: (01)20643169704057(017)20190120
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 12/21/2018

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: 01/20/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: A208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 12/15/2018; 10/15/2018; 10/15/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/17/2018; 12/20/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 68