MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Break (1069); No Display/Image (1183); Display or Visual Feedback Problem (1184); Power Problem (3010)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 05/02/2021

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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose and high blood pressure on (b)(6) 2021, with blood glucose of 365 mg/dl. Customer was in emergency room as a result of high blood glucose level. The customer was treated with insulin pump. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer also stated that insulin pump had blank display. Customer stated that the display was not blank less than 30 seconds and did not return. Customer stated that the contacts on the battery cap were not missing or damaged. Customer did not allege that insulin pump was under delivering. The insulin pump will be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 11811520
• MDR Text Key: 250180567
• Report Number: 2032227-2021-144716
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169873834
• UDI-Public: (01)000000643169873834
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG2H8GM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: Z-0955-2020

Patient Treatment Data

Date Received: 05/12/2021 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR, UNOMED INF SET