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	Hypoglycemia (1912)
Date of Event	05/12/2018
Type of Reportable Event	Serious Injury
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer was reported via phone call that, the customer was hospitalized on an unknown date with low blood glucose of 11 mg/dl and current blood glucose was 223 mg/dl.Customer stated that, this occurred saturday night, he must of fell, then customer ended up in hospital and then was sent to the emergency room.Customer was wearing the pump at time of hospitalization.Customer was unable to complete care-link upload.Based on customer report customer does not allege pump was over delivering.The sensor and insulin pump will not be returned for analysis.

• 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: 7564568
• Report Number: 2032227-2018-04376
• Device Sequence Number: 16772972
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(17)190121(10)A218
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/21/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: A218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MMT-1780KPK
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Weight: 160