Customer reported via phone call via phone call that they were hospitalized on (b)(4), 2021 due to high blood glucose level and diabetes ketoacidosis.The blood glucose level of customer was 970 mg/dl.It was unknown that customer was using the insulin pump system within 48 hours of reported high blood glucose event.Customer had experienced symptom related to reported incident including nausea, weakness, vomiting.Customer was treated with intravenous insulin drip.Customer insisted that insulin pump was not working properly and not giving them proper insulin.Insulin pump was taking more than one rewind during reservoir change.The insulin pump will be returned for analysis.
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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 has been updated and provided in b5 section of this report.
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