(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.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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A complete analysis and testing of the insulin pump showed that, unable to perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test due a pump error 38 occurring during testing on (b)(6) 2023 12:51:00.000.Successfully downloaded history files and traces using thus.Pump error 38 was found in the history files on (b)(6) 2022 22:19:27.000.Pump was cut open to perform visual inspection and found moisture damage on the pcba 1, pcba 2, force sensor and motor home switch.Unable to do the motor test to due moisture damage.P-cap locks properly into the reservoir compartment, however, damage to the retainer ring was noted during visual inspection.The following were noted during visual inspection: battery tube threads - cracked, scratched case, overlay scratched, cracked keypad overlay, keypad overlay peeling, stained keypad overlay, cracked case (battery tube), cracked case-corner of belt clip rails, pillowing keypad overlay, label damage (serial number label faded, stained and peeling; end cap address label faded, stained and peeling) and cracked retainer.Pump error 38 was confirmed due to moisture damage on the motor assembly.Retainer ring damage was confirmed during analysis.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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