(b)(4).On (b)(6) 2022 customer returned pump for an alleged moisture damage.Insulin pump alarmed during rewind due to corrode the motor home switch.Unable to perform rewind test, basic occlusion test, occlusion test, prime, excessive no delivery test and displacement test due to alarm.Pump history download using this was successful.However, there is no data available on (b)(6) 2022, unable to perform data analysis for motor error, alarms.Cut and open pump to visual inspection moisture damage found on the lcd board.The test p-cap/reservoir does lock into place properly.The following were noted during visual inspection: insulin pump had cracked battery tube threads, cracked reservoir tube lip, stained address/serial number label.E70 alarm during rewind due to corrode the motor home switch, moisture damage confirmed.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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