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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected 3 opened/used partial sensors and performed visual inspection and found 1 of 3 sensors with cannula retracted inside sensor base and found broken cannula broken part is missing.Second sensor found with blood at the contact pad, and 3rd sensor found cannula broken, broken part is missing.Unable to confirm customer received sensor in said condition due to customer returned opened/used.Missing 3 needles.
Event or Problem Description
The customer reported via phone call sensor anomaly.The customer¿s blood glucose was unknown.The customer advised their sensors did not function properly.The customer was advised to return the sensors for analysis and that replacement sensors would be sent out.
Additional Manufacturer Narrative
Inspected 3 opened or used partial sensors and performed visual inspection and found 1 of 3 sensors with cannula retracted inside sensor base and found broken cannula broken part is missing.2nd sensor found with blood at the contact pad, and 3rd sensor found cannula broken, broken part is missing.See picture attachment file for details.Unable to confirm customer received sensor in said condition due to customer returned opened or used.Missing 3 needles.

• 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: 7950450
• Report Number: 2032227-2018-39888
• Device Sequence Number: 11144460
• Product Code: OZP
• UDI-Device Identifier: 20643169704057
• UDI-Public: (01)20643169704057(017)20181228
• 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): 02/14/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2018
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: L287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 223