Retainer ring=black on (b)(6) 2022 customer called in with the following concern: after replacing with a new insulin pump patient is experiencing low bgs.P-cap locked in place properly during testing.Device was successfully downloaded using (thump software).The adapt tool was utilized to search for alarms that may have occurred in the past or during complain call that might of trigger the reason complain.Device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test and self test.During download review no relevant alarms confirm in download history files to confirm complain code.Proceed it by cutting unit open and perform a visual inspection of connectors and electronic assemblies.Per visual inspection no moisture damage or anomalies noted during visual inspection.No physical damage noted during visual inspection.In conclusion, customer concerns are not confirmed.No relevant alarms noted in download history review and testing of the unit was successful.(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.
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