MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
|
Back to Search Results |
|
Model Number MMT-1712K |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
|
Event Date 02/22/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Information received by medtronic indicated that the customer experienced hyperglycemia with a blood glucose value of 612 mg/dl , customer also noticed the pump error 23 , battery cap damage and contact missing.The customer admitted for ketoacidosis that happen twice within a period of 48 hours and found there was a loss of communication.Troubleshooting was performed.It was found that the customer has treated the high blood glucose event stayed in hospital.The customer was using the pump within 48 hours of the reported event.Unknown whether the auto-mode feature was active or not.No further patient complications were reported.It is unknown whether the customer will continue or discontinue to use the device and the insulin pump will not be returned for failure analysis.
|
|
Event Description
|
The information which was submitted in the initial report was incorrect.Hence, the information has been provided in sections b1, h1 with this report.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|
|