Serial number: (b)(6).Software version: 3.8.5.Color: grey.Battery life remaining: <10 months.Unit paired successfully to commercial mobile app.My inpen menu displayed: the following values were dialed and dosed: 4.0u and 3.0 were recorded, 4.0 u dialed and 2.5 u were recorded.The inpen values transmitted did not matched bolus dialed.The screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately.No resistance was observed when dosing without a cartridge installed.The screw advanced every time 30.0u was dialed and dosed until the screw reached max extension.No physical damage to injection foot or inpen was noted.Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs were misalign and off the encoder guide.This causes an unexpected travel of the encoder pattern wheel creating a misalignment of the encoder patter wheel and the encoder contact pcba.This also created contamination build up caused by encoder wheels rubbing at the walls of the encoder guide.It was determined contamination and/or misalignment can cause the encoder to not make electrical connections therefore, missing a count or if there is a short, you may have extra pulses which will cause inaccuracy.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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