Per visual inspection: dose window missing.Broken off piece at cartridge holder.Front shell does not stay attached.Inpen paired to the commercial app.Inpen received with leadscrew 1/4 of travel.Performed bayonet bond investigation and found leadscrew and cartridge stop rotating together when dispensing due to broken bayonet bond.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.Performed front cap investigation using test inpen.In conclusion: inpen received with broken off piece at the cartridge holder.Physically damaged cartridge holders can affect insulin delivery.The customer concern of physical damage at cartridge holder was confirmed.Leadscrew anomaly was confirmed due to bayonet bond failure.Cosmetic damage was confirmed due to missing dose window.Difficult to dial/dose was not confirmed.Cap anomaly was confirmed.H6: type of investigation code-10 investigation findings code-3194 investigation conclusions-140 = in30af.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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