MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711W; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711W

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Displays Incorrect Message (2591); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

It was reported via phone call that they had a power error detected alarm.The serial number on the back of the device had worn away.The customer¿s blood glucose was 17 mmol/l.Troubleshooting was performed but due to the serial number being worn off, the device was replaced.The device was not returned for analysis.

Manufacturer Narrative

Insulin pump trace download analysis confirmed the pump alarmed power error alarm.The power management tool confirmed power error alarm was triggered when the backup battery loaded voltage (loaded vlith) was less than 3.5 volts for 4 consecutive hours due to connector resistance electrical board.After disconnecting and reconnecting the internal battery connector on electrical board, the pump was monitored and functioned properly.Device was received with missing serial number label.

• Brand Name: 640G INSULIN PUMP MMT-1711W
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 6862858
• MDR Text Key: 86285391
• Report Number: 2032227-2017-47734
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169739482
• UDI-Public: (01)00643169739482
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711W
• Device Catalogue Number: MMT-1711W
• Device Lot Number: HG17SBR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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