Serial number: (b)(6).Software version: 3.8.5.Color: grey.Battery life remaining: <10 months.Per visual inspection: no physical damaged to cap, cartridge holder or inpen was noted.Customer reports: leadscrew not retracting back into inpen.The inpen paired to the commercial app with small pairing dose.The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted.Hard to dial more than 4 units.The injection button was removed and no dust / debris under the dose button or dose knob was noted.Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Also contamination build up found caused by encoder wheel tabs rubbing at the walls of the dose nut.In conclusion: it was determined from destructive analysis that the leadscrew anomaly was caused by a pattern wheel misalignment due to an encoder base bond failure.This can could affect insulin delivery.The customer complaint of leadscrew retracting into inpen 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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