MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 03/22/2017

Event Type  Injury  

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.

Event Description

The customer reported that they were hospitalized due to high blood glucose.The customer was hospitalized either late (b)(6) 2017 or very early (b)(6)2017 with a blood glucose of 1300 mg/dl.She stated that she was moving and then started throwing up and her blood glucose was 500 mg/dl.The customer said she was going to take the pump off but could not wake up and cannot remember how long the pump was off of her.She stated that it wasn't the pump's fault.The ambulance came and took her to the hospital with a blood glucose of 1300 mg/dl.She believes that she had a stomach virus and was stressed from moving and work.The cause of the hospitalization was diabetic ketoacidosis.The customer said that she was in a coma for five days, was on life support and was released once her blood glucose was stable and she was out of the coma, which was on (b)(6) 2017.She said that she was not wearing the insulin pump at the time of the hospitalization and was without it for less than 48 hours.She declined troubleshooting.The insulin pump will not be returning for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 6718362
• MDR Text Key: 80193990
• Report Number: 2032227-2017-29027
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 131