Per visual inspection: injection button and dose detent broken off, exposing electronic assembly.Dosing window is missing and front shell does not stay attached.No physical damage to cartridge holder was noted.Dose detent bond was broken cleanly due to a broken dose detent adhesive bond exposing the electronics.Making it difficult to dial a dose.Inpen paired to commercial app.Unable perform functional test due to physical damage.Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked and broken.Performed dialing alignment inspection.No misalignment of the dial was noted.In conclusion: it¿s difficult to dose normally due to broken off injection button due to a broken dose detent adhesive bond.Therefore, the customer concern of dosing button broke off was confirmed.However, no misalignment of the dial was 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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