Serial number: n/a software version: n/a color: blue battery life remaining: n/a customer reports: problem with inpen wasn't delivering an insulin when dialing a dose.When twisted the plunger back all the way and twisted the screw the plunger/injection foot its not moving.The injection foot is sticking out when dialing a dose to zero it out.When priming it the injection foot moved towards the end of the cartridge but when injection foot is already at the end of the cartridge and trying to dial a dose again to push some insulin the injection foot moved backwards away from the needle/ at the end of the cartridge.Per visual inspection: no physical damage.The screw is not bent.The leadscrew advances properly when dosing, however, retracts when dialing doses due to dust/debris under the dose button, on washer, on the dose detent and dose knob.Unable to perform functional test due to screw anomaly.In conclusion: the customer complaint of leadscrew anomaly 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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