MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Battery (420); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  Malfunction  

Manufacturer Narrative

Insulin pump passed sleep current measurement, active current measurement, self test and displacement test. No unexpected low battery alarm noted during testing. Pump trace download analysis confirmed the pump alarmed power loss alarm, replace battery alert, replace battery now alarm. The power management tool indicated abnormal behavior of the lithium backup battery loaded voltage (loaded vlith) as shown on the power management graph and confirmed power loss alarm, replace battery alert and replace battery now alarm due to connector resistance j6 /pcb 1. After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the pump was monitored and functioned properly. Unit was received with partially detached reservoir retainer, scratched case, minor scratched lcd window and faded serial number label.

Event Description

The customer reported via phone call that insulin pump had battery issue. The blood glucose at the time of the incident was unknown. The device will be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7649743
• MDR Text Key: 112871811
• Report Number: 3004209178-2018-86563
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER
• Reporter Occupation: PATIENT
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/29/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device LOT Number: HG1CPZY
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/29/2016
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown