On the event date february 21, 2022.Customer returned insulin pump for an alleged a33 alarm.Insulin pump passed the displacement test and rewind test.A33 alarm during basic occlusion test due to loose/protruded drive support disk.Unable to perform prime/a33 test, excessive no delivery test and occlusion test due to a33 alarm.Insulin pump history download using thds was successful.No a33 alarm was not found in the formatted history file on the event date.Unable to confirm date & time of alarm and force sensor and motor data due to corrupted history file.A47 alarms found on the history file which caused corrupted data.A47 alarms are due to the insulin pump not having power for a long period of time.Insulin pump was cut/open and inspected no moisture damage or component damage found inside the insulin pump.Test reservoir lock properly inside the reservoir tube.The following were noted during visual inspection: cracked reservoir tube lip and cracked battery tube threads.Insulin pump confirmed with a33 alarm during the basic occlusion test due to loose/protruded support disk.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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