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	Hyperglycemia (1905)
Date of Event	03/31/2018
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 they experienced high blood glucose of 429 mg/dl which was treated with manual injection.Blood glucose at the time of the call was 398 mg/dl.The customer stated that the insulin pump alarmed insulin flow blocked.Troubleshooting was performed.The customer confirmed insulin exited the tubing after disconnecting at the quick release.The canula was removed and was not bent.It was explained that the alarm may be due to a possible site related issue and advised to change the entire infusion set system.The customer also reported that there was no communication between the transmitter and sensor.Troubleshooting was performed.The insulin pump will not be returned for analysis.The sensor will 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: 7474088
• Report Number: 2032227-2018-02795
• Device Sequence Number: 1717771
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(017)20190224
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 04/30/2018

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: 02/24/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: B248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 179