(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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Additional information has been received which was not included with the initial report.The information has been provided in section h10 with this report.On (b)(6) 2022, the insulin pump was returned due to customer allegation to insulin pump possibly over delivering.The insulin pump passed all functional testing including the self-test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and the dat test at 0.0872 inches.Successfully downloaded history files and traces using thus.Successfully uploaded to carelink and generated reports.No over delivery anomaly noted during testing.In further full review of the insulin pump history on the event date of november 03, 2022 found daily total of bolus insulin delivered to be 0 units.Insulin pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor or force sensor.Test p-cap and reservoir locked properly into reservoir compartment during testing.The insulin pump was received with a scratched case, pillowing keypad overlay, serial number label faded.In summary, customer allegation for insulin pump possibly over delivering not confirmed during full functional testing.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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