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

Model Number MMT-1712K

Device Problems Air Leak (1008); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problem Hyperglycemia (1905)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

It was reported via phone call that the insulin pump had under delivery,over delivery.The blood glucose level was 350mg/dl,195mg/dl,41mg/dl.Customer treated with manual injection,insulin pump and for low treated with glucose tablet.Customer was assisted with troubleshooting.Customer state that there were no air bubbles.Customer was assisted with high pressure test and found that bubbles were in the tubing.Customer alleging the insulin pump because customer was experiencing unexplained high blood glucose, low blood glucose.The product will not be returned for the analysis.

• Brand Name: 640G INSULIN PUMP MMT-1712K
• 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: 7633189
• MDR Text Key: 112314853
• Report Number: 3004209178-2018-84726
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00763000065201
• UDI-Public: (01)00763000065201
• 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
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Device Lot Number: A000415607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2018
• Date Device Manufactured: 12/12/2017
• 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