MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7020B ENLITE3 US; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020B
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the sensor cannula was broken.The customer¿s blood glucose level was unknown at the time of the incident.The customer states the sensor cannula was broken off in two pieces.The sensor will be returned for analysis.
Additional Manufacturer Narrative
Inspected one opened or used sensor, we found needle separated from sensor base.Inspected insertion needle for burrs or hooks and dull needle tip defects and none were found introducer needle passed per specifications.Also, we found cannula as a whole.No broken or missing parts were observed during analysis.
Additional Manufacturer Narrative
Inspected one opened or used sensor, we found needle separated from sensor base.Inspected insertion needle for burrs or hooks and dull needle tip defects and none were found introducer needle passed per specifications.Also, we found cannula as a whole.No broken or missing parts were observed during analysis.The follow up report one was not submitted.The additional information has been provided with this report, follow up report two.

• Brand Name: SENSOR MMT-7020B ENLITE3 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: 7155121
• Report Number: 2032227-2017-78395
• Device Sequence Number: 738554
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(017)20181021
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/13/2018

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: 10/21/2018
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: J117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 03/08/2018; 03/08/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 03/08/2018; 03/13/2018
• 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: 170