Customer reported via phone call that they had hospitalized due to high blood glucose level on (b)(6) 2021.Blood glucose level at the time of hospitalization was 560 mg/dl and was in the hospital for two weeks.Customer stated six months before there blood glucose was 1200 mg/dl, went to emergency room due to chest pain and blood glucose was over 1000 mg/dl, another blood glucose level was 500 mg/dl.The infusion set was bent.Customer had been using insulin pump within 48 hours of reported.Customer reported retainer ring was cracked and reservoir was unable to lock in place.The insulin pump will be returned for analysis.
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This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020 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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