It was reported via phone call that the customer passed away in hospice care.The customer was hospitalized on (b)(6) 2021 due to mobility issue.The caller stated that the customer was insulin diabetic, fell and broke their hip that may have led to the customer's passing.The customer¿s had high blood glucose, they had taken morphine and blood glucose went to 593 mg/dl.The customer was wearing the insulin pump at the time of death.The customer was not using sensors.The customer's wife did not felt that it was a pump problem, it was their body shutting down from the cancer, and being sedentary, and the high blood pressure.The caller declined to return the insulin pump for analysis.
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(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 event has been updated with this report in section b5.
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