Per visual inspection: broken off piece at the cartridge holder.No physical damage to inpen front or back shell.Unit paired successfully to commercial app.Inpen received with leadscrew 1/4 of travel.Cartridge holder broken off plastic pieces stuck inside inpen/cartridge holder cavity.Inpen passed front cap investigation.In conclusion: inpen received with broken off piece at the cartridge holder and did not lock in place due to broken off piece being stuck inside inpen/cartridge holder cavity.Physically damaged cartridge holders can affect insulin delivery.Therefore, the customer concern of cartridge holder not locking in place was 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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