Customer did not have high blood glucose on september 1, 2019.Customer reported having a low blood glucose of 20mg/dl.On september 1, 2019.Paramedics were dispatched and she was taken to the emergency room.Customer was then hospitalized.Customer said she might have given herself too much insulin.Pump was used at the time of the incident.It is unknown if sensor was used.Per svn 314203233, pump was returned back in 2019 but not for analysis.
|
(b)(4).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.Information related to the summary has been updated and provided with this report in section b5.
|