MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715KL |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the insulin pump had pump error alarm.Customer stated they were able to clear the alarm and they were not able to rewind insulin pump.No harm requiring medical intervention was reported.The customer will continue to use the device.
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Manufacturer Narrative
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(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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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Manufacturer Narrative
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P-cap locked in place properly during testing.Unit was successfully downloaded using (thus software).The adapt tool was utilized to search for alarms that may have occurred in the past or during complain call that might of trigger the reason complain.Unit passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test and self test.Unit was primed with no reservoir in place and rewind to home position.No unexpected or constant pump error 38 alarm noted during testing.However, in using adapt tool to review recordings it shows multiple pump error 38 on 02/22/2022 and on 02/23/2022.Unit was cut open and perform a visual inspection on connectors and electronic assemblies.Per visual inspection all connectors including motor flex connector were plugged in properly.No moisture damage noted during visual inspection.Unit also received with cracked case(battery tube).Due to the consistency of pump error 38 recorded in download history motor is isolated.Unit may have had an intermittent failure not detected during our testing.In conclusion no pump error alarm 38 alarm was noted during testing.Unit may have had an intermittent failure not detected during our testing.However due to the consistency of pump error 38 recorded in download history motor is isolated.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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