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 Codes	Hypoglycemia (1912); No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
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
Customer reported via phone call that they experienced low blood glucose level of over 45 mg/dl.The customer treated through glucose carb intake.The customer also reported getting inaccurate readings with the sensor.Customer's current blood glucose level is 137 mg/dl.Customer declined troubleshooting for low blood glucose.The sensor was not returned for analysis.
Additional Manufacturer Narrative
The information provided that the event date with the initial report was incorrect.The correct information has been included with this report.

• 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: 7649054
• Report Number: 2032227-2018-07691
• Device Sequence Number: 2376460
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(17)190416(10)D168
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 05/18/2020

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: 04/16/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: D168
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 148