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 Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Unit passed displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement and selftest.No unexpected power loss alarms or blank display anomalies noted during testing.Unexpected replace battery alerts and replace battery now alarms were present in the pump history file due to connector resistance issue (j6).Connector for j6 on pcba 1 was properly connected during visual inspection.The j6 connector was disconnected and reconnected then monitored for 2 days with the unit functioning properly during testing as shown in the power management graph.Unit received with scratched casing, minor scratches on lcd window, scratches on display window cover and pillowing keypad overlay.

Event Description

The customer reported via phone call that the insulin pump had a replace battery now alarm without getting a low battery alert.Customer also reported getting a power loss alarm and blank display but was resolved during troubleshooting.Blood glucose level at the time of the incident was 164 mg/dl.The customer was advised that the insulin pump would be replaced and agreed to return the device 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: 7640762
• MDR Text Key: 112560401
• Report Number: 3004209178-2018-85503
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: HG1A6RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 215