Serial number: (b)(4), software version: 3.8.3, color: pink, battery life remaining: <3 months.Customer reports: inpen app is not recording the exact doses dialed on the inpen, the dose is not showing in the active insulin.Per visual inspection: received with missing dosing window.Unit paired successfully to commercial app.My inpen menu displayed: the following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0u and 16.0u.All values displayed accurately in the logbook.All doses were written to the app logbook within 1 minute.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.In conclusion: inpen received working as design.No malfunctions noted during testing that could affect insulin delivery.The patient complaint of dose log inaccuracies or not showing the active insulin could not be confirmed.Inpen will be sent to s.D for further analysis.
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Serial number: (b)(6).Software version: 3.8.3.Color: pink.Battery life remaining: <3 months.Customer reports: inpen app is not recording the exact doses dialed on the inpen, the dose is not showing in the active insulin.Per visual inspection: received with missing dosing window.Unit paired successfully to commercial app.My inpen menu displayed: the following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0u and 16.0u.All values displayed accurately in the logbook.All doses were written to the app logbook within 1 minute.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.In conclusion: inpen received working as design.No malfunctions noted during testing that could affect insulin delivery.The patient complaint of dose log inaccuracies or not showing the active insulin could not be confirmed.Inpen will be sent to s.D for further analysis.2/11/2022 per neta glaser, cannot replicate issues.All encoder inconsistencies in investigation can be tied back to too-fast dosing during testing.Slower testing showed consistently accurate results.Unit tested ok and no dose log anomalies were witness in san diego.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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