Information received by medtronic indicated that the customer has been experiencing low blood glucose episodes that required emergency medical service multiple times.On (b)(6) 2019, customer experienced hypoglycemia with a blood glucose value of 20 mg/dl at the time of the event and a current blood glucose value of 47 mg/dl.The customer was unconscious and had a seizure, admitted to ems/er/hospitalization for an overnight stay, and treated by iv glucose, and food for the low blood glucose event.The customer alleged that the pump was over-delivering.The customer stated no symptoms related to hypoglycemia.Troubleshooting was performed and found that the pump was used within 48 hours of the low blood glucose event and the smart guard/auto mode was active at the time of the low blood glucose event.The insulin pump will not be returned for analysis.
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(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.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.
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