(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.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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Additional information has been received which was not included with the initial report.The information has been provided in section b5 with this report.Retainer = black.Case type = ngp.Customer returned pump for an alleged retainer ring damage, unspecified alarm, and exposure to moisture found on 07-jul-2022.Pump was received with a critical pump error (open book image) alarm.Unable to perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, active current measurement test and self test due to critical pump error (open book image) alarm.Pump was cut open to perform visual inspection and found moisture damage on the pcba 1, motor, force sensor, and in corroded battery tube.Successfully utilized crest and thus to download history files, comlink3 files, and traces.Critical pump error (open book image) alarm confirmed and was triggered by a pump error 35 fatal alarm confirmed in the history files on 06-jul-2022 at 09:42:00.000 due to moisture damage on the force sensor.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: pillowing keypad overlay, label damage (faded serial number).Critical pump error (open book image) alarm confirmed due to pump error 35.Pump error 35 alarm confirmed due to moisture damage.Pump exposed to moisture confirmed at pcba 1, motor, force sensor, and in corroded battery tube.Retainer ring damage not 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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