(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, the pump passed the displacement test, active current test, sleep current test and self test.During the rewind test, pump errors 3, 42, 53, and 54 were noted.Unable to perform the prime/seating test, basic occlusion test, force sensor test, or occlusion test due to failed rewind test.Successfully downloaded history files and traces using thus.Pump error 54 was present during testing and in the history download on event date of 12/05/2022 22:24:25.000.(file number = 32149, and line number = 223).Pump error 53 was present during testing and in the history download on event date of 12/05/2022 22:24:25.000 (file number = 16, and line number = 439).Pump error 42 was present during testing and in the history files on event date of 12/05/2022 22:39:54.000 (file number = 13, and line number = 457).Pump error 3 was present during testing and in the history files on (b)(6) 2022 11:08:14.000.Pump error 2 was found in the history files on event date of 12/05/2022 22:39:52.000.Tested with a test p-cap and the test p-cap locked in place properly.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor or force sensor.The motor was tested outside of the device on the ngp stb3 and passed.The following were noted during visual inspection: scratched case, cracked keypad overlay, cracked belt clip rails, pillowing keypad overlay.Pump errors 3, 42, 53, and 54 were confirmed during testing.Pump error 2 was confirmed in the history files.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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