MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hyperglycemia (1905)

Event Date 02/15/2018

Event Type  Injury  

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.

Event Description

The customer reported via phone call that he gave himself too much insulin and needed to turn off the insulin bolus. The customer reported that his sugar glucose was 9. 2 and he needed to suspend his insulin pump. The customer stated that he delivered his bolus about half hour and was trying to enter 30grams but accidentally entered 50 grams and now he had 20 units of insulin been delivered. The customer current blood glucose level was 17. 9 mmol/l. Troubleshooting was performed. The customer also stated that he had starchy dinner and caused his blood glucose levels to go high as 17. 9 mmol/l and then he went to treat for the high and entered the incorrect amount of carbs. The customer reported that he was experiencing low blood glucose levels about past half hour. The customer stated that his blood glucose level was 10 mmol/l. The patient treated the blood glucose with four sugar tablets and four tablespoons of sugar. During troubleshooting, the customer stated that they are unsure if the programming is accurate. The customer stated that the current blood glucose level was 7. 0 mmol/l. Troubleshooting was not completed at the time of call. The customer reported that the blood glucose level have been stable at 6. 6 mmol/l for the past 15 minutes.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 7310059
• MDR Text Key: 101398185
• Report Number: 3004209178-2018-54258
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG1SFK8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/02/2018 Patient Sequence Number: 1