Software version: n/a color: blue battery life remaining: n/a customer reports: cap no longer attaching into inpen.Per visual inspection: missing dose window, broken pieces from cartridge holder and cap no longer staying attached.The leadscrew was received 1/4 of its travel, the leadscrew was rewound properly.Leadscrew 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 30.0unit was dialed and dosed until the screw reached max extension.Several attempts were made to pair inpen, every time app displayed dose doesn't match.The inpen does not pair with commercial mobile app.Inpen dose button was removed and electronic stack, flex connector and battery were inspected for electrical faults, moisture damage, workmanship and cracked or damage components.The electronic assembly was found with traces of water damage to battery.A battery test was performed and battery measure at 0.012 volts.Inpen was found to be corroded.In conclusion: it was determined that cause of inpen not pairing was cause by corrosion to the battery.In addition, missing dose window, broken off pieces from cartridge holder and cap no longer staying attached due to broken snap arms noted.Customer concern of cap no longer staying attached 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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