MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
|
Back to Search Results |
|
Model Number MMT-1715K |
Device Problem
Excess Flow or Over-Infusion (1311)
|
Patient Problems
Hypoglycemia (1912); Nausea (1970); Vomiting (2144); Lethargy (2560)
|
Event Date 04/05/2022 |
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 low blood glucose on unknown date and time with blood glucose of 40 mg/dl.The customer's current blood glucose is unknown.The customer did experienced symptoms such as lethargic, nausea, vomiting result of low blood glucose.Troubleshooting was performed.No further patient complications were reported.
|
|
Event Description
|
Customer reported going to the emergency room and being hospitalized for low blood glucose of 40 mg/dl, micro heart attack, kidney failure, and congestive heart failure on (b)(6) 2022 between 6 to 8pm.Customer has discontinued the pump since the low.Per (b)(4), the retainer ring was damaged on (b)(6) 2021.The insulin pump had been dropped onto carpet, concrete, and tile flooring.On (b)(6) 2022, customer said that there is a break/crack in the retainer ring and the gasket black o-ring comes out.The reservoir was unable to lock in place when inserted into pump.Pump was used at the time of the low.It is unknown if sensor was used.
|
|
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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.The information related to event has been updated and provided in b5 section of this report.
|
|
Search Alerts/Recalls
|
|
|