MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1780KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number MMT-1780KPK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Headache (1880); Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364)

Event Date 09/21/2020

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 via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2020 with blood glucose of over 700 mg/dl or 715 mg/dl.The customer's current blood glucose was 364 mg/dl.The customer experienced symptoms such as nausea, other muscle ache, headache and chest pain.The customer was treated with insulin pump, manual injection, insulin pen, insulin infusion drip.Troubleshooting was done for high blood glucose and under delivery.Customer did not use auto mode feature active insulin delivery at time of high blood glucose.The insulin pump will be returned for analysis.

• Brand Name: PUMP MMT-1780KPK 670G PATHWAY BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• 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: 10611034
• MDR Text Key: 209331879
• Report Number: 2032227-2020-184787
• Device Sequence Number: 1
• Product Code: OZP
• UDI-Device Identifier: 000000643169939219
• UDI-Public: (01)000000643169939219
• 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: Other
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Device Lot Number: HG1X11L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Date Device Manufactured: 06/22/2017
• 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
• Treatment: FRN-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 143