Serial number: (b)(6).Software version: 3.8.4.Color: pink.Battery life remaining: <7 months.Customer reports: that her dose it is off by.5 or 1 unit its every time she takes a dose adds an extra.5 or 1 unit to dose to equal to amount she needed.Per visual inspection: no physical damage to injection foot or inpen was noted.Inpen received with leadscrew halfway of the travel.Re-wound screw.No drag was observed, 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.Unit paired successfully to commercial app with a 1.5 dose.The following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0u and the following values were shown at the app, 1.0 u, 1.5 u, 2.5 u and 0.5 u.In conclusion: the customer complaint dose log anomaly was confirmed.Pending further analysis that will be perform in san diego location.02/11/2022 per neta glaser pattern wheel is misaligned due to broken encoder base bond.Plastic is discolored and oily.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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