MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712W; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712W

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.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 Description

The customer reported via phone call that for about 10 to 15 days, her pump¿s display has had lines across the screen and that it is hard to read.Her blood glucose was 155 mg/dl.She has had to change the battery every two days.The customer said that the battery cap looks fine and is not damaged.The pump will be returning for analysis.

Manufacturer Narrative

Unit was not received stuck in the manufacturing mode.Unit was received with vertical rainbow lines discoloration on the display due to disrupted liquid crystal cause by slightly bend lcd glass.Unit was received with operating currents within specification.Unit passed self-test, rewind, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within specific range.No low battery alert/alarm noted during testing or in the insulin pump trace download.Unit was received with cracked case on the back at the battery tube area and battery tube threads.Unit was received with faded serial number label.Unit was received with minor scratched display window, case and keypad overlay texture damaged.

• Brand Name: 640G INSULIN PUMP MMT-1712W
• 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: 6830691
• MDR Text Key: 84132694
• Report Number: 2032227-2017-42346
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169577701
• UDI-Public: (01)00643169577701
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712W
• Device Catalogue Number: MMT-1712W
• Device Lot Number: HG0QXC4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/30/2018
• 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