On 09-feb-2022 customer alleged the pump having a17, a21 alarm, battery lasts less than expected (charging battery anomaly).Unit passed operating currents, self-test, of no power test and displacement test.No unexpected low battery, a17 alarms noted during testing.However, unit received a21 alarmed after battery change and resets time/date to factory default.Pump history download using thds was successful.However, no a17, a21 alarms reported on event date 09-feb-2022.Pump was cut and open found no moisture/damage on the electronics, battery connector, battery tube, motor, vibrator, keypad flex tail, keypad trace noted during visual inspection.Swapping out test interface boards confirms a21 alarmed and measure c13 voltage leak at interface board.Unit had stained address/serial number label, stained end cap sticker.The test reservoir locked in place properly and no anomaly noted.In conclusion, a17 alarm, battery lasts less than expected (charging battery anomaly) not confirmed.A21 alarmed after battery change 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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