Per visual inspection: no physical damage to cartridge holder or inpen front or back shell was noted.The inpen paired to the commercial app.The leadscrew was received 1/2 it's travel.Inpen passed baseline and wireless functionality.App logbook displayed: 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u.Performed leak test and no fluid leaks were noted outside the fluid pathway.Inpen passed front cap investigation.In conclusion: no fluid leaks were noted on inpen.Inpen working as design.Therefore, the customer concern of insulin leaking could not be confirmed.No delivery anomaly noted.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 reported insulin was leaking while trying to do dosage, also alleges that inpen may be broken.Troubleshooting was performed and found no misaligned, slipping or difficult to turn.The customer will discontinue using the inpen and revert to back up plan as per health care provider instructions.The insulin pen will be returned for analysis.
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