Per visual inspection: broken piece at the cartridge holder and front shell does not fit securely to inpen.Cartridge holder broken off plastic pieces stuck inside inpen/cartridge holder cavity.Inpen failed front cap investigation.Several attempts were made to pair inpen, every time app displayed ¿inpen not found¿.The inpen does not pair with commercial mobile app and inpen did not transmit to manufacturing app.Unable to perform baseline/wireless functionality due to not pairing to commercial mobile app.Unable to perform functional test due to dial/dose not functioning properly.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.Pending further investigation performed in san diego location.In conclusion per nr: difficult to dial/dose confirmed and no comm other device to mobile-unresolved confirmed due to broken bayonet bond.In conclusion per san diego analysis: pen was not able to connect to mobile app due to broken bayonet bond.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.
|