Serial number: n/a.Software version: n/a.Color: pink.Battery life remaining: n/a.Customer reports: leadscrew will not rewind.Dialed 20 units and the button will not press.Leadscrew is not moving as intended.Per visual inspection: missing dosing window.Several attempts were made to pair inpen, every time app displayed dose doesn't match and inpen not found.The inpen does not pair with commercial mobile app.Leadscrew received fully re-wound.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.However, after a couple of dial and dose attempts the leadscrew started working as expected and was able to dial and delivered with out issues.In conclusion: an intermittent leadscrew anomaly noted during testing.Per san diego investigations: destructive testing showed that leadscrew anomaly was caused by a pattern wheel misalignment due to an encoder base bond failure.Therefore, the customer complaint of hard to rewind, hard to dial, hard to push to give insulin was confirmed due to encoder base failure.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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