This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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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Information received by medtronic indicated that the customer experienced hyperglycemia with a blood glucose value at the time of incident : 665 mg/dl and current blood glucose value: 336 mg/dl.Troubleshooting was performed and found that the customer was treated with insulin pump, manual injection and intravenous insulin infusion in hospital overnight, emergency medical service.The customer reported headache, vomiting as symptoms related high blood glucose level.The insulin pump was used within 48 hours and the auto mode/smart guard feature was not active at the time of the event.The customer alleged the pump was underdelivered as blood glucose was not going down and noticed the reservoir did not move but also had the insulin flow blocked.No further patient complications were reported.The customer will continue using the insulin pump.The insulin pump will not be returned for analysis.
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