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

Model Number MMT-1711K

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Hyperglycemia (1905); Tachycardia (2095); Chills (2191)

Event Date 02/10/2019

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 that the insulin pump was under delivering because blood glucose did not in normal rang and customer¿s diabetic specialist nurse said insulin pump was not working.The customer blood glucose level went up to 20 mmol/l, was told to treat with manual injection, blood glucose was 17 mmol/l, treated with insulin pump and went up to over 33 mmol/l, treated with the insulin pump and later treated with the injection and blood glucose went up to 23 mmol/l up to 26 mmol/l at time of incident and current blood glucose level was 18 mmol/l.The customer was assisted with troubleshooting.Customer reports the symptoms related to their high blood glucose such as difficulty breathing, shivering, and heart beating fast.Customer reports insulin pump was not worn during a medical procedure or test around a magnetic image resonance.Customer reports they performed displacement test and test results passed.Customer was able to perform high pressure test at that time.Customer reports they performed the high pressure test and test results passed.The device will not be returned for analysis.

Manufacturer Narrative

Device passed the rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and the dat test at 0.0871 inches.Installed a water filled reservoir, primed pump, monitored for a day, and programmed with multiple boluses during monitoring period.Observed liquid exit the tubing during the bolus deliveries.All boluses delivered properly and were listed in the daily history screen.No bolus history or delivery anomalies noted during testing.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• 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 ; 8185464805
• MDR Report Key: 8365192
• MDR Text Key: 137056407
• Report Number: 3004209178-2019-58997
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00763000068998
• UDI-Public: (01)00763000068998
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG2LN0G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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