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

Model Number MMT-1711H

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2017

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.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.

Event Description

The customer reported via phone call that the insulin pump had a critical pump error and a red x on the display.Blood glucose level at the time of the incident was not provided.The customer was advised that the insulin pump would be replaced but did not return the device for analysis.

Manufacturer Narrative

Device passed displacement test, rewind test, prime or seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement and selftest.Device was monitored and functioning properly.No critical pump error during testing.(b)(4).

• Brand Name: 640G INSULIN PUMP MMT-1711H
• 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: 6660327
• MDR Text Key: 78256919
• Report Number: 2032227-2017-22747
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169554924
• UDI-Public: (01)00643169554924
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/05/2019

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-1711H
• Device Catalogue Number: MMT-1711H
• Device Lot Number: HG0NZ8X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 06/01/2019
• Supplement Dates FDA Received: 06/05/2019
• 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