MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Inaccurate Delivery (2339); High Test Results (2457)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 05/26/2018

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's wife reported via phone call that they were hospitalized due to high blood glucose and diabetes ketoacidosis on (b)(6) 2018 at 9:30 am with blood glucose over 900 mg/dl. The current blood glucose was 252 mg/dl and another blood glucose was 500 mg/dl. The customer was treated with the bolus and insulin drip. Troubleshooting was done for high blood glucose and under delivery. The customer was wearing the insulin pump at the time of hospitalization. The insulin pump will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 7643566
• MDR Text Key: 112517864
• Report Number: 3004209178-2018-85748
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/27/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device LOT Number: HG1L9U1
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/12/2017
• 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: 06/27/2018 Patient Sequence Number: 1