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

Model Number MMT-1715KL

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 01/29/2020

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.(b)(4).

Event Description

Medtronic legal received information regarding that customer was brought to emergency room had hyperglycemia with blood glucose reading of 1300 mg/dl and diabetic ketoacidosis from the attorney of the family.Customer stated that the issue started from last (b)(6) 2019 and the issue with insulin pump was it seemed accepting numbers and to be delivering insulin but blood glucose reading kept on elevating.Customer stated that 911 was called to provide aid because blood glucose kept on rising and 2 different ambulance came along with paramedics.Customer stated that the local hospital could not provide further assistance because of high blood glucose and was in coma.Customer reported that later they were air lifted to a trauma center and spent 3 days in icu and 3 more days in recovery.Customer stated after a week and a half later, they had a hand surgery wherein a plate was placed using 8 screws.Customer was treated with insulin shots every hour.The device will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 9674967
• MDR Text Key: 185951413
• Report Number: 3004209178-2020-65184
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000166519
• UDI-Public: (01)00763000166519(17)220922
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2022
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG3RTSF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/06/2020
• Date Device Manufactured: 09/23/2019
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 168